Non-Pneumatic Tourniquet Suppliers
Limit companies to: Worldwide USA
Rudolf Riester GmbH | Address: Bruckstr. 31, Jungingen D-72417, Germany 
www.riester.de | Send Inquiry | Phone: +49-(7477)-92-70-0
FDA Registration: 8010482 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Medical Thermometers, Direct Ophthalmoscopes, Indirect Ophthalmoscopes, Thermometers, Nasal & Ear Specula, Pulse Oximeters, ...
Rudolf Riester GmbH supplies medical instruments such as otoscopes, and ophthalmoscopes for doctor's use. We are accredited with ISO-9001 certification. Our products meet CE and FDA standards. Our more...
www.riester.de | Send Inquiry | Phone: +49-(7477)-92-70-0
FDA Registration: 8010482 Annual Revenues: USD 10-25 Million Employee Count: ~150 Quality: ISO 9001, CE Certified
Products: Medical Thermometers, Direct Ophthalmoscopes, Indirect Ophthalmoscopes, Thermometers, Nasal & Ear Specula, Pulse Oximeters, ...
Rudolf Riester GmbH supplies medical instruments such as otoscopes, and ophthalmoscopes for doctor's use. We are accredited with ISO-9001 certification. Our products meet CE and FDA standards. Our more...
Sarstedt AG & Co. | Address: Rommelsdorfer Straße, Postfach 1220, Numbrecht 51582, Germany
www.sarstedt.com | Send Inquiry | Phone: +49-(2293)-305-0
FDA Registration: 2242368 Year Established: 1961 Annual Revenues: USD 25-50 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Blood Lancets, Incubators, Capillary Blood Collection Tubes (FDA Code: GIO), Diagnostic Aids, Blood Collect Tubes, Carts, ...
Sarstedt AG & Co. manufactures & distributes equipment and consumables in the field of medicine & research. The S-Monovette® for PFA 100 contains a buffered citrate preparation that is required fo more...
www.sarstedt.com | Send Inquiry | Phone: +49-(2293)-305-0
FDA Registration: 2242368 Year Established: 1961 Annual Revenues: USD 25-50 Million Employee Count: ~200 Quality: ISO 9001, CE Certified
Products: Blood Lancets, Incubators, Capillary Blood Collection Tubes (FDA Code: GIO), Diagnostic Aids, Blood Collect Tubes, Carts, ...
Sarstedt AG & Co. manufactures & distributes equipment and consumables in the field of medicine & research. The S-Monovette® for PFA 100 contains a buffered citrate preparation that is required fo more...
VBM Medizintechnik Gmbh | Address: Einsteinstr. 1, Sulz a.N. D-72172, Germany
www.vbm-medical.com | Send Inquiry | Phone: +49-(7454)-95-96-10
FDA Registration: 8010939 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Cricothyrotomy Kits (FDA Code: OGP), Emergency Cricothyrotomy Kit, Adult Cricothyrotomy Kit, Elastic Bandages (FDA Code: FQM), Pneumatic Tourniquet (FDA Code: KCY), Reservoir Bag (FDA Code: BTC), ...
VBM Medizintechnik Gmbh offers tourniquets, and anesthesia, emergency, and pediatric products. We develop and manufacture tourniquets for I.V. regional anesthesia with double cuffs, and tourniquets fo more...
www.vbm-medical.com | Send Inquiry | Phone: +49-(7454)-95-96-10
FDA Registration: 8010939 Annual Revenues: USD 5-10 Million Employee Count: ~70 Quality: ISO 9001, CE Certified
Products: Cricothyrotomy Kits (FDA Code: OGP), Emergency Cricothyrotomy Kit, Adult Cricothyrotomy Kit, Elastic Bandages (FDA Code: FQM), Pneumatic Tourniquet (FDA Code: KCY), Reservoir Bag (FDA Code: BTC), ...
VBM Medizintechnik Gmbh offers tourniquets, and anesthesia, emergency, and pediatric products. We develop and manufacture tourniquets for I.V. regional anesthesia with double cuffs, and tourniquets fo more...
HEBUmedical GmbH | Address: Badstrasse 8, Tuttlingen D-78532, Germany
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
www.hebumedical.de | Send Inquiry | Phone: +49-(7461)-94 710
FDA Registration: 9611112
Products: Forceps (FDA Code: HTD), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Lacrimal Probes (FDA Code: HNL), Surgical Retractor Systems (FDA Code: GAD), ...
HEBUmedical GmbH specializes in the research, development, design and production of medical equipments. We are continuously engaged with the rationalization of new manufacturing sequences as well as t more...
AS Medizintechnik Gmbh | Address: Sattlerstrasse 15, Tuttlingen 78532, Germany
www.as-medizintechnik.de | Send Inquiry | Phone: +49-(7461)-966326
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), ...
AS Medizintechnik Gmbh specializes in the production of surgical instruments and disposal sterile products. Our product line comprises of non-stick bipolar forceps, propylux, detachable laminectomy an more...
www.as-medizintechnik.de | Send Inquiry | Phone: +49-(7461)-966326
Products: Forceps (FDA Code: HTD), Probes (FDA Code: HXB), Saws (FDA Code: HSO), Gastroenterologic Needle Holder (FDA Code: FHQ), Self-Retaining Retractors (FDA Code: FFO), Wire Twisters (FDA Code: HXS), ...
AS Medizintechnik Gmbh specializes in the production of surgical instruments and disposal sterile products. Our product line comprises of non-stick bipolar forceps, propylux, detachable laminectomy an more...
Karl-A. Huber Inh. Rainer Huber | Address: Freiburgstr. 32, Tuttlingen 78532, Germany
Phone: +49-(7461)-27 18
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Surgical Retractor Systems (FDA Code: GAD), Tonsil Snares (FDA Code: KBZ), Uterine Curettes (FDA Code: HCY), ...
Karl-A. Huber Inh. Rainer Huber offers medical instruments. Our products include multiple retractor, curette, stylets, tourniquets, ear instrument, nasal instruments, elevator and dilator. more...
Phone: +49-(7461)-27 18
Products: Self-Retaining Retractors (FDA Code: FFO), Self-Retaining Retractor Systems, Knee Self-Retaining Retractors, Surgical Retractor Systems (FDA Code: GAD), Tonsil Snares (FDA Code: KBZ), Uterine Curettes (FDA Code: HCY), ...
Karl-A. Huber Inh. Rainer Huber offers medical instruments. Our products include multiple retractor, curette, stylets, tourniquets, ear instrument, nasal instruments, elevator and dilator. more...
Pro-Health Product Ltd. | Address: 4b, Guoxian Commercial Building, No.41,Hengfu Rd, Guangzhou 510095, China 
www.prohealthcn.com | Send Inquiry | Phone: +86-(20)-8397466, 83497456, 83497
FDA Registration: 3006784717 Quality: ISO13485 Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), ...
Pro-Health Product Ltd. specializes in pharmaceutical and medical promotional marketing items as well as health-care/first aid products. Our medical product line includes wooden tongue depressors, abs more...
www.prohealthcn.com | Send Inquiry | Phone: +86-(20)-8397466, 83497456, 83497
FDA Registration: 3006784717 Quality: ISO13485 Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Arm Slings (FDA Code: ILI), ...
Pro-Health Product Ltd. specializes in pharmaceutical and medical promotional marketing items as well as health-care/first aid products. Our medical product line includes wooden tongue depressors, abs more...
Firstar Healthcare Co., Ltd. | Address: No.4-5, 2nd Industrial District, Dong Shen Cun, Dongchong Town ,Panyu District, Guangzhou 511475, China
www.china-firstar.com | Send Inquiry | Phone: +86-(20)-28865699
FDA Registration: 3003887292
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Infant Tongue Depressor (FDA Code: FMA), ...
Firstar Healthcare Co., Ltd. is an exporter of first aid kits and health care products. Our products include surgical, blood collection, wound care, surgical dressings and home care products. We also more...
www.china-firstar.com | Send Inquiry | Phone: +86-(20)-28865699
FDA Registration: 3003887292
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Infant Tongue Depressor (FDA Code: FMA), ...
Firstar Healthcare Co., Ltd. is an exporter of first aid kits and health care products. Our products include surgical, blood collection, wound care, surgical dressings and home care products. We also more...
Medplus, Inc. | Address: 4th Flr, Bldg C-4, Gaosha Ind., Zone, Zhongcun, Panyu Dist., Guangzhou 511495, China
Phone: +86-(20)-347-73390
FDA Registration: 3006550380
Products: Surgical Skin Markers (FDA Code: FZZ), Skin Marker (FDA Code: FZZ), Anesthetic Gas Mask (FDA Code: BSJ), Heat and Moisture Condenser (FDA Code: BYD), Percutaneous Biopsy Device (FDA Code: MJG), Non-Pneumatic Tourniquet (FDA Code: GAX), ...
Medplus, Inc. deals with anesthetic gas masks, heat and moisture condensers & non-pneumatic tourniquets. We also offer percutaneous biopsy devices, skin markers and surgical skin markers. more...
Phone: +86-(20)-347-73390
FDA Registration: 3006550380
Products: Surgical Skin Markers (FDA Code: FZZ), Skin Marker (FDA Code: FZZ), Anesthetic Gas Mask (FDA Code: BSJ), Heat and Moisture Condenser (FDA Code: BYD), Percutaneous Biopsy Device (FDA Code: MJG), Non-Pneumatic Tourniquet (FDA Code: GAX), ...
Medplus, Inc. deals with anesthetic gas masks, heat and moisture condensers & non-pneumatic tourniquets. We also offer percutaneous biopsy devices, skin markers and surgical skin markers. more...
Sanxin Medical Devices Group | Address: No.999 Fushan Road, Xiaolan Industry, Park, Nanchang Jiangxi China., Nanchang 330200, China
www.sanxin-med.cn | Phone: +86-(791)-5988819
FDA Registration: 3005246939
Products: Oxygen Masks (FDA Code: BYG), Disposable Syringes, Catheter Accessories (FDA Code: KGZ), Venous Catheter, Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Sanxin Medical Devices Group manufactures a series of disposable syringes, I.V. sets, catheters & tubes, hemodialysis and vaginal supplies. Our products include sterile syringes, infusion sets, hypode more...
www.sanxin-med.cn | Phone: +86-(791)-5988819
FDA Registration: 3005246939
Products: Oxygen Masks (FDA Code: BYG), Disposable Syringes, Catheter Accessories (FDA Code: KGZ), Venous Catheter, Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Sanxin Medical Devices Group manufactures a series of disposable syringes, I.V. sets, catheters & tubes, hemodialysis and vaginal supplies. Our products include sterile syringes, infusion sets, hypode more...
Trucare Medical Co. Ltd. | Address: No.40-402,Jincheng Garden,Gulou District, Nanjing 210003, China
Phone: +86-(25)-58804547
Products: Elastic Bandages (FDA Code: FQM), Adhesive Tape Solvent (FDA Code: KOX), Non-Pneumatic Tourniquet (FDA Code: GAX), Non-Sterile Corrugated Rubber Sheath For Non-Indwelling Catheter (FDA Code: NNY), ...
Trucare Medical Co. Ltd. deals with adhesive tape solvents and bandages. more...
Phone: +86-(25)-58804547
Products: Elastic Bandages (FDA Code: FQM), Adhesive Tape Solvent (FDA Code: KOX), Non-Pneumatic Tourniquet (FDA Code: GAX), Non-Sterile Corrugated Rubber Sheath For Non-Indwelling Catheter (FDA Code: NNY), ...
Trucare Medical Co. Ltd. deals with adhesive tape solvents and bandages. more...
Honsun Nantong Company Ltd | Address: No.8, Tongxing Road, Nantong Economic &, Technological Development Area, Nantong 226009, China
Send Inquiry | Phone: +86-(513)-85986718
Products: Blood pressure Cuffs (FDA Code: DXQ), Aneroid Sphygmomanometer, Clinical Mercury Thermometers (FDA Code: FLK), Non-Invasive Blood Pressure Monitor, Manual Stethoscope (FDA Code: LDE), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), ...
Honsun Nantong Company Ltd specializes in the production of aneroid sphygmomanometers with stethoscope. Our aneroid sphygmomanometer with stethoscope-is used as a non-invasive blood measurement system more...
Send Inquiry | Phone: +86-(513)-85986718
Products: Blood pressure Cuffs (FDA Code: DXQ), Aneroid Sphygmomanometer, Clinical Mercury Thermometers (FDA Code: FLK), Non-Invasive Blood Pressure Monitor, Manual Stethoscope (FDA Code: LDE), Non-Invasive Blood-Pressure Measurement System (FDA Code: DXN), ...
Honsun Nantong Company Ltd specializes in the production of aneroid sphygmomanometers with stethoscope. Our aneroid sphygmomanometer with stethoscope-is used as a non-invasive blood measurement system more...
Sifang Medical Corporation | Address: No. 501, No. 43 Cangsong Road, Ningbo 315012, China
www.sifangmedical.com | Send Inquiry | Phone: +86-(574)-87844588
FDA Registration: 3003967977
Products: Pediatric Stethoscope, Dual Head Stethoscope, Single Head Stethoscope, Disposable Stethoscopes, Training Stethoscope, Fetal Stethoscope (FDA Code: HGN), ...
Sifang Medical Corporation specializes in production of stethoscopes. Our products include deluxe single head & dual-head stethoscopes, sprague rappaport type stethoscopes, disposable type stethoscope more...
www.sifangmedical.com | Send Inquiry | Phone: +86-(574)-87844588
FDA Registration: 3003967977
Products: Pediatric Stethoscope, Dual Head Stethoscope, Single Head Stethoscope, Disposable Stethoscopes, Training Stethoscope, Fetal Stethoscope (FDA Code: HGN), ...
Sifang Medical Corporation specializes in production of stethoscopes. Our products include deluxe single head & dual-head stethoscopes, sprague rappaport type stethoscopes, disposable type stethoscope more...
Ningbo Evergrand Medical Ltd | Address: 31 Yaohang Steet,Ningbo,China, Ningbo 315010, China
www.evergrandonline.com | Send Inquiry | Phone: +86-(574)-27882323
FDA Registration: 3006210673 Quality: CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Patient Examination Gowns and Capes (FDA Code: FME), ...
Ningbo Evergrand Medical Ltd manufactures and exports disposable medical products and healthy products. Our products include underpads, dental bibs, syringes, bandages, first aid products, surgical dr more...
www.evergrandonline.com | Send Inquiry | Phone: +86-(574)-27882323
FDA Registration: 3006210673 Quality: CE Mark Certified
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Patient Examination Gowns and Capes (FDA Code: FME), ...
Ningbo Evergrand Medical Ltd manufactures and exports disposable medical products and healthy products. Our products include underpads, dental bibs, syringes, bandages, first aid products, surgical dr more...
Shandong Shingna Medical Products Co., Ltd. | Address: No.37 Lanyan Avenue, Zhangdian, Zibo, Shangdong 255000, China
www.shingna.com | Send Inquiry | Phone: +86-(533)-3587-867
FDA Registration: 3005382793 Quality: ISO 9001 Certified
Products: Island Dressings, Transparent Dressings, Adhesive Bandages (FDA Code: KGX), Transparent Medical Dressings, Adhesive Dressing, Wound Dressings, ...
Shandong Shingna Medical Products Co., Ltd. is engaged in the research and production of medical dressings. Our products are transparent semi-permeable dressing, transparent island dressings, PU surgi more...
www.shingna.com | Send Inquiry | Phone: +86-(533)-3587-867
FDA Registration: 3005382793 Quality: ISO 9001 Certified
Products: Island Dressings, Transparent Dressings, Adhesive Bandages (FDA Code: KGX), Transparent Medical Dressings, Adhesive Dressing, Wound Dressings, ...
Shandong Shingna Medical Products Co., Ltd. is engaged in the research and production of medical dressings. Our products are transparent semi-permeable dressing, transparent island dressings, PU surgi more...
Shanghai Jini Rubber & Plastic Products Factory | Address: 393 Sanxuan Rt. Sandun Town, Nanhui District, Shanghai 201312, China
Phone: +86-(21)-51329179
FDA Registration: 3005280269
Products: Elastic Bandages (FDA Code: FQM), Non-Pneumatic Tourniquet (FDA Code: GAX), ...
Shanghai Jini Rubber & Plastic Products Factory offers non-pneumatic tourniquets. more...
Phone: +86-(21)-51329179
FDA Registration: 3005280269
Products: Elastic Bandages (FDA Code: FQM), Non-Pneumatic Tourniquet (FDA Code: GAX), ...
Shanghai Jini Rubber & Plastic Products Factory offers non-pneumatic tourniquets. more...
Angel International Trading Ltd. | Address: Room 431, Xintian Building, No. 84, An Yuan Road, Shanghai 200060, China
Phone: +86-(310)-3287981
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), ...
Angel International Trading Ltd. deals with medical dressing products. We offer adhesive bandages, adult tongue depressor, infant tongue depressor, disposable medical bed, junior tongue cleaner and pr more...
Phone: +86-(310)-3287981
Products: Tongue Depressors (FDA Code: FMA), Adhesive Bandages (FDA Code: KGX), Infant Tongue Depressor (FDA Code: FMA), Adult Tongue Depressor (FDA Code: FMA), Junior Tongue Depressor (FDA Code: FMA), Non-Surgical Tongue Depressor (FDA Code: FMA), ...
Angel International Trading Ltd. deals with medical dressing products. We offer adhesive bandages, adult tongue depressor, infant tongue depressor, disposable medical bed, junior tongue cleaner and pr more...
Shanghai Winner Medical Instruments Co., Ltd. | Address: 98 Jie chen Road,Shihudang Industrial Park, Songjiang, Shanghai 201617, China
Send Inquiry | Phone: +86-(21)-57841010
Quality: ISO 9001 , ISO 13485 Certified
Products: Elastic Cohesive Bandages, Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Bandages Adhesive Plastic, Bandages, ...
Shanghai Winner Medical Instruments Co., Ltd. manufactures healthcare bandages and sports care products. Our Cowin is a non woven and cohesive flexible bandage that features an elastic nonwoven substr more...
Send Inquiry | Phone: +86-(21)-57841010
Quality: ISO 9001 , ISO 13485 Certified
Products: Elastic Cohesive Bandages, Adhesive Bandages (FDA Code: KGX), Elastic Bandages (FDA Code: FQM), Adhesive Elastic Bandage Tape, Bandages Adhesive Plastic, Bandages, ...
Shanghai Winner Medical Instruments Co., Ltd. manufactures healthcare bandages and sports care products. Our Cowin is a non woven and cohesive flexible bandage that features an elastic nonwoven substr more...
Shanghai Amsino Medical Devices Co., Ltd. | Address: 668-5 Hua Jiang Rd., Shanghai 201803, China
Phone: +86-(215)-9117385
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Straight Catheter (FDA Code: EZD), ...
Shanghai Amsino Medical Devices Co., Ltd. is a manufacturer of adult tongue depressors, catheter accessories, non-surgical isolation gowns, oxygen masks, surgical trays, urine leg bags, surgical razor more...
Phone: +86-(215)-9117385
Products: Oxygen Masks (FDA Code: BYG), Forceps (FDA Code: HTD), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Straight Catheter (FDA Code: EZD), ...
Shanghai Amsino Medical Devices Co., Ltd. is a manufacturer of adult tongue depressors, catheter accessories, non-surgical isolation gowns, oxygen masks, surgical trays, urine leg bags, surgical razor more...
Shanghai Neo-Medical Import & Export Co., Ltd. | Address: 16/B Oujiang B/D, Zhaojiabang Road, Shanghai 200030, China
Phone: +86-(21)-546-52962
FDA Registration: 3005327291
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Shanghai Neo-Medical Import & Export Co., Ltd. offers adhesive bandages, cannula clamps, electrocardiograph electrodes, infusion catheters, tongue depressors and surgical trays. more...
Phone: +86-(21)-546-52962
FDA Registration: 3005327291
Products: Gastroenterologic Needle Holder (FDA Code: FHQ), Urine Collection Leg Bags (FDA Code: FAQ), Tongue Depressors (FDA Code: FMA), Catheter Accessories (FDA Code: KGZ), Infusion Catheter (FDA Code: JCY), Adhesive Bandages (FDA Code: KGX), ...
Shanghai Neo-Medical Import & Export Co., Ltd. offers adhesive bandages, cannula clamps, electrocardiograph electrodes, infusion catheters, tongue depressors and surgical trays. more...
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FDA Code / Regulation: GAX / 878.5900
A nonpneumatic tourniquet is a device consisting of a strap or tubing intended to be wrapped around a patient's limb and tightened to reduce circulation.
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 878.9.
