Hot/Cold Water Bottle Suppliers
Limit companies to: Worldwide USA
Hospira, Inc. | Address: 275 N. Field Dr., Lake Forest, Illinois 60045, USA 
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
www.hospira.com | Send Inquiry | Phone: +1-(224)-212-2000
FDA Registration: 1925262 Year Established: 1930 Annual Revenues: > USD 1 Billion Employee Count: ~16000 Quality: ISO 9002 Certified
Products: Anesthesia Equipment, Irrigating Solutions, Pulmonary Artery Catheters, Anesthetics, Antibiotics, Aspirators, ...
Hospira, Inc. focuses on medication delivery systems & critical care devices, which include the next-generation patient-controlled analgesia device, lifeCare PCA®, the plum A+® multichannel in more...
Teleflex Medical | Address: PO Box 12600, Research Triangle Park, North Carolina 27709, USA
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
www.teleflexmedical.com | Send Inquiry | Phone: +1-(919)-544-8000
FDA Registration: 1044475 Annual Revenues: USD 50-100 Million Employee Count: ~380 Quality: ISO 9001, CE Certified
Products: Absorbable Sutures (FDA Code: GAK), General Diagnostic Supplies, General Medical Supplies, General Sutures/Needles, Non-Absorbable Sutures (FDA Code: GAO), Suture Needles, ...
Teleflex Medical, a division of Teleflex Incorporated, is a supplier of medical devices, surgical instruments & disposable medical products. We are a global outsource provider that focuses on medical more...
Sunbeam Products, Inc. | Address: 2381 Executive Center Dr., Boca Raton, Florida 33431, USA
www.sunbeam.com | Phone: +1-(561)-912-4100
FDA Registration: 1043899
Products: Neonatal Disposable Blood Pressure Cuffs, Body Composition Analyzer (FDA Code: MNW), Ice Bags (FDA Code: KYR), Non-Direct Patient Interface Humidifier (FDA Code: KFZ), Patient Stand-On Scale (FDA Code: FRI), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Sunbeam Products, Inc. offers air conditioners, dehumidifiers, fans, hair care, heaters, heating pads and humidification products. Our mattress pads include heated, quilted heated, waterproof heated a more...
www.sunbeam.com | Phone: +1-(561)-912-4100
FDA Registration: 1043899
Products: Neonatal Disposable Blood Pressure Cuffs, Body Composition Analyzer (FDA Code: MNW), Ice Bags (FDA Code: KYR), Non-Direct Patient Interface Humidifier (FDA Code: KFZ), Patient Stand-On Scale (FDA Code: FRI), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Sunbeam Products, Inc. offers air conditioners, dehumidifiers, fans, hair care, heaters, heating pads and humidification products. Our mattress pads include heated, quilted heated, waterproof heated a more...
Rece International Corp. | Address: 5881 N.W. 151st St., Ste. 111, Miami Lakes, Florida 33014, USA
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
Phone: +1-(305)-3626555
FDA Registration: 3003965134
Products: Oxygen Masks (FDA Code: BYG), Adult Tongue Depressor (FDA Code: FMA), Hydrophilic Wound Dressings (FDA Code: NAC), Blood Collection Lancet (FDA Code: FMK), Emesis Basin (FDA Code: FNY), Elastic Stocking (FDA Code: ILG), ...
Rece International Corp. provides surgical and medical equipments such as adult tongue depressors, blood collection lancets, elastic stockings, emesis basins, hydrophilic wound dressings, venturi low more...
C. R. Bard, Inc., Bard Medical Div. | Address: 8195 Industrial Blvd., Covington, Georgia 30209, USA
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
www.bardmedical.com | Send Inquiry | Phone: +1-(770)-784-6100, 800-526-4455
FDA Registration: 3006082230 Quality: ISO 9001 Certified
Products: Arthroscopes (FDA Code: HRX), Adhesive Bandages (FDA Code: KGX), Autotransfusion Apparatus (FDA Code: CAC), Active Electrosurgical Electrode (FDA Code: FAS), AV Shunt Accessories (FDA Code: KNZ), Anti-Infective Latex Foley Catheters, ...
C. R. Bard, Inc., Bard Medical Div. provides products and services that meet the needs of healthcare providers & patients. We specialize in disease state management offering the industry's comprehensi more...
Tetra Medical Supply Corporation | Address: 6364 West Gross Point Road, Niles, Illinois 60714, USA
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
www.tetramed.com | Send Inquiry | Phone: +1-(847)-647-0590, 800-621-4041
FDA Registration: 1418270 Year Established: 1913 Annual Revenues: USD 1-5 Million Employee Count: ~10 Quality: CE Certified
Products: General Medical Supplies, Wrist/Arm/Shoulder Braces & Supports, Adhesive Bandages (FDA Code: KGX), Adhesive Dressing, Bariatric Abdominal Binder, Panel Elastic Abdominal Binder, ...
Tetra Medical Supply Corporation focuses on bandages, dressings, orthopedic softgoods, and hot & cold therapy products. Our portfolio of customers includes hospitals, surgeons, podiatrists, chiropract more...
Thermionics Corp. | Address: 1214 Bunn Avenue, Suite 5, Springfield, Illinois 62703, USA
www.thermipaq.com | Send Inquiry | Phone: +1-(217)-529-4280, 800-800-5728
Year Established: 1990 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Heat Therapy Pads, Heating Pads, Powered Heating Pad (FDA Code: IRT), Reusable Hot /Cold Pack (FDA Code: IME), Therapeutic Hot & Cold Pads, Therapeutic Moist Heat Pads, ...
Thermionics Corp. offers effective hot/cold pain therapy products. We provide thermpaq, a hot/cold clay-based pack that goes from freezer to microwave and maintains therapeutic temperature for 30 minu more...
www.thermipaq.com | Send Inquiry | Phone: +1-(217)-529-4280, 800-800-5728
Year Established: 1990 Annual Revenues: USD 1-5 Million Employee Count: ~10
Products: Heat Therapy Pads, Heating Pads, Powered Heating Pad (FDA Code: IRT), Reusable Hot /Cold Pack (FDA Code: IME), Therapeutic Hot & Cold Pads, Therapeutic Moist Heat Pads, ...
Thermionics Corp. offers effective hot/cold pain therapy products. We provide thermpaq, a hot/cold clay-based pack that goes from freezer to microwave and maintains therapeutic temperature for 30 minu more...
Mabis DMI Healthcare | Address: 1931 Norman Drive, Waukegan, Illinois 60085, USA
www.mabis.net | Send Inquiry | Phone: +1-(800)-526-4753
FDA Registration: 1422443 Year Established: 1992 Annual Revenues: USD 25-50 Million
Products: Stethoscopes, Thermometers, Bowls & Basins, Disposable Syringes, EKG Supplies, Aspirators, ...
Mabis DMI Healthcare manufactures nebulizers, blood pressure monitors & thermometers. Our 10-second digital thermometer displays temperature measurements within 10-seconds and cleans easily. Our mist more...
www.mabis.net | Send Inquiry | Phone: +1-(800)-526-4753
FDA Registration: 1422443 Year Established: 1992 Annual Revenues: USD 25-50 Million
Products: Stethoscopes, Thermometers, Bowls & Basins, Disposable Syringes, EKG Supplies, Aspirators, ...
Mabis DMI Healthcare manufactures nebulizers, blood pressure monitors & thermometers. Our 10-second digital thermometer displays temperature measurements within 10-seconds and cleans easily. Our mist more...
Creche Innovations | Address: 9243 Cody St., Overland Park, Kansas 66214, USA
www.crecheinnovations.com | Send Inquiry | Phone: +1-(877)-387-8505
FDA Registration: 3006806517
Products: Baby Food Warmer, Blood and Fluid Warmers, Warmers, Hot/Cold Water Bottle (FDA Code: FPF), ...
Creche Innovations specializes in the production of Penguin Nutritional Warmer™. Our Penguin Nutritional Warmer™ is designed for warming frozen breast milk. It is used to allow the frozen more...
www.crecheinnovations.com | Send Inquiry | Phone: +1-(877)-387-8505
FDA Registration: 3006806517
Products: Baby Food Warmer, Blood and Fluid Warmers, Warmers, Hot/Cold Water Bottle (FDA Code: FPF), ...
Creche Innovations specializes in the production of Penguin Nutritional Warmer™. Our Penguin Nutritional Warmer™ is designed for warming frozen breast milk. It is used to allow the frozen more...
Fomentek | Address: 1743 Elm St., P.O. Box 1202, Lake Charles, Louisiana 70601, USA
www.fomentek.com | Send Inquiry | Phone: +1-(337)-436-9922
FDA Registration: 2318036
Products: Ice Packs, Hot/Cold Water Bottle (FDA Code: FPF), ...
Fomentek provides hot/cold water bottles and ice packs. Our Fomentek™ bags are used by massage therapists, physical therapists, pain management clinics, health spas and chiropractors. Our Foment more...
www.fomentek.com | Send Inquiry | Phone: +1-(337)-436-9922
FDA Registration: 2318036
Products: Ice Packs, Hot/Cold Water Bottle (FDA Code: FPF), ...
Fomentek provides hot/cold water bottles and ice packs. Our Fomentek™ bags are used by massage therapists, physical therapists, pain management clinics, health spas and chiropractors. Our Foment more...
Apothecary Products, Inc. | Address: 11750 12th Ave South, Burnsville, Minnesota 55337-1295, USA
www.apothecaryproducts.com | Send Inquiry | Phone: +1-(800)-328-2742
FDA Registration: 2183416 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~130
Products: Splints, Boxes, Glass & Plastic Bottles, General Medical Supplies, Turnkey Glove Boxes, Polymer Glove Boxes, ...
Apothecary Products, Inc. distributes pharmacy supplies. We deliver retail products in a variety of categories like medical compliance aids, health & beauty care, baby care and travel accessories. Our more...
www.apothecaryproducts.com | Send Inquiry | Phone: +1-(800)-328-2742
FDA Registration: 2183416 Year Established: 1975 Annual Revenues: USD 25-50 Million Employee Count: ~130
Products: Splints, Boxes, Glass & Plastic Bottles, General Medical Supplies, Turnkey Glove Boxes, Polymer Glove Boxes, ...
Apothecary Products, Inc. distributes pharmacy supplies. We deliver retail products in a variety of categories like medical compliance aids, health & beauty care, baby care and travel accessories. Our more...
Derma Sciences, Inc. | Address: 214 Carnegie Center Suite 300, Princeton, New Jersey 08540, USA
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
www.dermasciences.com | Send Inquiry | Phone: +1-(609)-514.4744
FDA Registration: 9680091 Year Established: 1991 Annual Revenues: USD 5-10 Million Employee Count: ~20
Products: Gauze, Gauze Dressings, Packings, Self-Adherent Wraps/Bandages, Tubular Gauzes, Ulcer, Burn & Wound Dressings, ...
Derma Sciences, Inc. manufactures & markets a complete line of products for wound and skin care. Our products can be broken down into five categories including advanced wound care, traditional wound c more...
Lifeline First Aid LLC | Address: 6713 Sw Bonita Rd., Suite 206, Tigard, Oregon 97224, USA
www.lifelinefirstaid.com | Send Inquiry | Phone: +1-(877)-3778243
FDA Registration: 3002714597
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), First Aid Kits, Emergency First Aid Kit (FDA Code: LRR), Hot/Cold Water Bottle (FDA Code: FPF), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Lifeline First Aid LLC provides first aid kits, road kits, accessories, survival kits, water proof kits, bottles & kits, disaster kits and products for breast cancer awareness. Our first aid kits incl more...
www.lifelinefirstaid.com | Send Inquiry | Phone: +1-(877)-3778243
FDA Registration: 3002714597
Products: Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), First Aid Kits, Emergency First Aid Kit (FDA Code: LRR), Hot/Cold Water Bottle (FDA Code: FPF), Disposable Hot/Cold Pack (FDA Code: IMD), ...
Lifeline First Aid LLC provides first aid kits, road kits, accessories, survival kits, water proof kits, bottles & kits, disaster kits and products for breast cancer awareness. Our first aid kits incl more...
Cara, Inc. | Address: 255 Warwick Industrial Drive, Warwick, Rhode Island 02886-2417, USA
www.caraincorporated.com | Send Inquiry | Phone: +1-(401)-732 6535
FDA Registration: 1221553
Products: Syringes, Ice Bags (FDA Code: KYR), Heating Pads, Vinyl Synthetic Exam Gloves, Non Dental Irrigating Syringe (FDA Code: KYZ), Electrical Heating Pad, ...
Cara, Inc. is a manufacturer and distributor of water bottles/fountain syringes, ice bags/ice packs, electric heating pads, microwave heating pads, feminine syringes, vinyl gloves, dermatological cott more...
www.caraincorporated.com | Send Inquiry | Phone: +1-(401)-732 6535
FDA Registration: 1221553
Products: Syringes, Ice Bags (FDA Code: KYR), Heating Pads, Vinyl Synthetic Exam Gloves, Non Dental Irrigating Syringe (FDA Code: KYZ), Electrical Heating Pad, ...
Cara, Inc. is a manufacturer and distributor of water bottles/fountain syringes, ice bags/ice packs, electric heating pads, microwave heating pads, feminine syringes, vinyl gloves, dermatological cott more...
Hospital & Homecare Imp. & Exp. Co., Ltd. | Address: Room 608-611, No.5 Zhongtai Int. Plaza, No.311 Middle of Jiangdong Rd, Central Business Dist, Nanjing, Jiangsu, China 
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
www.aline-medical.com | Send Inquiry | Phone: +86-(25)-84573232
FDA Registration: 3006897996
Products: Adhesive Bandages (FDA Code: KGX), Adult Tongue Depressor (FDA Code: FMA), Cardiovascular Biopsy Needle (FDA Code: DWO), Adhesive Tape Solvent (FDA Code: KOX), Aerosol Adhesive Drape (FDA Code: KGT), Cast Bandage (FDA Code: ITG), ...
Hospital & Homecare Imp. & Exp. Co., Ltd. is mainly engaged in medical product development, covering thousands of products within the medical field. We provide Surgical & Optical Instruments, Laborato more...
Smith & Nephew Homecraft Ltd. | Address: Farnham Trading Estate, Farnham, Surrey GV9 9NQ, United Kingdom 
Phone: +44-(1252)-714-182
Annual Revenues: USD 25-50 Million Employee Count: ~220 Quality: ISO 9001 Certified
Products: Cervical Pillow, Contour Support Cervical Pillow, Cervical Pillow Roll, Wheelchair Ramps, Wheelchair Ramp for Disabled/Handicapped, Wheelchair Ramps, ...
Smith & Nephew Homecraft Ltd. provides gel filled insoles, arthritis sleep gloves, air-free hot water bottles, shower chairs, portable & folding commodes, heel & elbow pads, waterproof mattress protec more...
Phone: +44-(1252)-714-182
Annual Revenues: USD 25-50 Million Employee Count: ~220 Quality: ISO 9001 Certified
Products: Cervical Pillow, Contour Support Cervical Pillow, Cervical Pillow Roll, Wheelchair Ramps, Wheelchair Ramp for Disabled/Handicapped, Wheelchair Ramps, ...
Smith & Nephew Homecraft Ltd. provides gel filled insoles, arthritis sleep gloves, air-free hot water bottles, shower chairs, portable & folding commodes, heel & elbow pads, waterproof mattress protec more...
Link Treasure Limited Taiwan Branch | Address: No.22, Kuang-Fu Road, Chia-Tai Industrial, Tai Pao City, Chia Yi Hsien 61252, Taiwan 
Phone: +886-(3)-5208829
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Powered Wheelchair (FDA Code: ITI), Disabled/Handicapped Motorized 3-Wheeled Vehicle (FDA Code: INI), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Phone: +886-(3)-5208829
Products: Disabled/Handicapped Manual Wheelchair (FDA Code: IOR), Mechanical Wheelchair (FDA Code: IOR), Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS), Mechanical Walker (FDA Code: ITJ), Powered Wheelchair (FDA Code: ITI), Disabled/Handicapped Motorized 3-Wheeled Vehicle (FDA Code: INI), ...
Link Treasure Limited Taiwan Branch offers AC-powered patient lifts, disabled and handicapped manual wheelchairs, disabled and handicapped motorized 3-wheeled vehicles & disabled and handicapped hygie more...
Taiwan Stanch Co., Ltd. | Address: 2nd Fl., No. 51, Wu Chang St, Taipei R.O.C. 10, Taiwan
www.taiwanstanch.com | Send Inquiry | Phone: +886-(2)-25021879
FDA Registration: 9616306
Products: Heat or Cold Packs, Hot & Cold Therapy, Hot/Cold Accessories, Cold Therapy Kit, Hot or Cold Sport Wrap, Air Mattress, ...
Taiwan Stanch Co., Ltd. manufactures soft cold and hot gel packs for alleviating body discomforts. We are accredited with certifications such as ISO 9001, ISO 13485, GMP, CE, FDA and SGS. Our product more...
www.taiwanstanch.com | Send Inquiry | Phone: +886-(2)-25021879
FDA Registration: 9616306
Products: Heat or Cold Packs, Hot & Cold Therapy, Hot/Cold Accessories, Cold Therapy Kit, Hot or Cold Sport Wrap, Air Mattress, ...
Taiwan Stanch Co., Ltd. manufactures soft cold and hot gel packs for alleviating body discomforts. We are accredited with certifications such as ISO 9001, ISO 13485, GMP, CE, FDA and SGS. Our product more...
Valentine International Limited | Address: 8th Floor, No. 149, Sec. 2, Ta Tung Road, Hsichih, Taipei Hsien 221, Taiwan
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Ice Bags (FDA Code: KYR), Infusion Stand (FDA Code: FOX), Crutch (FDA Code: IPR), Wheelchair Commode Attachment (FDA Code: INB), Chair with Casters (FDA Code: INM), Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
www.valentine-dynalife.com | Send Inquiry | Phone: +886-(2)-8692-6662
FDA Registration: 8022890
Products: Ice Bags (FDA Code: KYR), Infusion Stand (FDA Code: FOX), Crutch (FDA Code: IPR), Wheelchair Commode Attachment (FDA Code: INB), Chair with Casters (FDA Code: INM), Sterile Corrugated Rubber Sheath For Nonindwelling Catheter (FDA Code: EYT), ...
Valentine International Limited specializes in the development of medical products. Our products include wheelchairs, bathroom safety aids, mobility, rehabilitation, orthopedic products, furniture & e more...
Enkay (India) Rubber Company Private Limited | Address: B-3, S.M.A. Industrial Estate, G.T. Karnal Road, Delhi 431813, India 
www.enkayrubber.com | Phone: +91-(11)-27693333
Products: Hot/Cold Water Bottle (FDA Code: FPF), ...
Enkay (India) Rubber Company Private Limited is a manufacturer and exporter of surgical goods. We manufacture rubber hot water bottles. We also manufacture and export human comfort products made from more...
www.enkayrubber.com | Phone: +91-(11)-27693333
Products: Hot/Cold Water Bottle (FDA Code: FPF), ...
Enkay (India) Rubber Company Private Limited is a manufacturer and exporter of surgical goods. We manufacture rubber hot water bottles. We also manufacture and export human comfort products made from more...
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FDA Code / Regulation: FPF / 880.6085
A hot/cold water bottle is a device intended for medical purposes that is in the form of a container intended to be filled with hot or cold water to apply heat or cold to an area of the body.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.
