Profile: A.M.G. Medical, Inc. is a manufacturer and wholesale distributor of medical professional and home healthcare products. We are an ISO 9001 certified company, and licensed by Health Canada as well as registered with the United States Food & Drug Administration (FDA). We manufacture, import, package, and distribute home healthcare and medical professional products. Our product line in ten core healthcare categories includes bathroom safety, daily living, disposables, equipment, home diagnostics, incontinence, instruments, mobility, patient care and professional diagnostics.
The company has revenues of USD 10-25 Million, has ~90 employees.
FDA Registration Number: 8022077
US Agent: Kevin Walls / Regulatory Insight, Inc.
Phone: +1-(720)-962-5412 Fax: +1-(720)-962-5413 E-Mail:
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• Non-Pneumatic Tourniquet (FDA Code: 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. |
• Non-Powered Sitz Bath (FDA Code: KTC / 890.5125) A nonpowered sitz bath is a device intended for medical purposes that consists of a tub to be filled with water for use in external hydrotherapy to relieve pain or pruritis and to accelerate the healing of inflamed or traumatized tissues of the perianal and perineal areas. |
• Non-Powered Traction Apparatus (FDA Code: HST / 888.5850) A nonpowered orthopedic traction apparatus is a device that consists of a rigid frame with nonpowered traction accessories, such as cords, pulleys, or weights, and that is intended to apply a therapeutic pulling force to the skeletal system. |
• Non-Sterile Absorbent Tipped Applicator (FDA Code: KXF / 880.6025) An absorbent tipped applicator is a device intended for medical purposes that consists of an absorbent swab on a wooden, paper, or plastic stick. The device is used to apply medications to, or to take specimens from, a patient. |
• Non-Surgical Tongue Depressor (FDA Code: FMA / 880.6230) A tongue depressor is a device intended to displace the tongue to facilitate examination of the surrounding organs and tissues. |
• Nonresorbable Gauze/sponge for External Use (FDA Code: NAB / 878.4014) A nonresorbable gauze/sponge for external use is a sterile or nonsterile device intended for medical purposes, such as to be placed directly on a patient's wound to absorb exudate. It consists of a strip, piece, or pad made from open woven or nonwoven mesh cotton cellulose or a simple chemical derivative of cellulose. This classification does not include a nonresorbable gauze/sponge for external use that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources. |
• Operating Room Shoe Cover (FDA Code: FXP / 878.4040) Surgical apparel are devices that are intended to be worn by operating room personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material. Examples include surgical caps, hoods, masks, gowns, operating room shoes and shoe covers, and isolation masks and gowns. Surgical suits and dresses, commonly known as scrub suits, are excluded. |
• Plastic Blood Lancets |
• Poly Patient Examination Glove (FDA Code: LZA / 880.6250) A patient examination glove is a disposable device intended for medical purposes that is worn on the examiner's hand or finger to prevent contamination between patient and examiner. |
• Reusable Hot /Cold Pack (FDA Code: IME / 890.5700) A cold pack is a device intended for medical purposes that consists of a compact fabric envelope containing a specially hydrated pliable silicate gel capable of forming to the contour of the body and that provides cold therapy for body surfaces. |
• Safety Walk Cane (FDA Code: KHY / 890.3075) A cane is a device intended for medical purposes that is used to provide minimal weight support while walking. Examples of canes include the following: A standard cane, a forearm cane, and a cane with a tripod, quad, or retractable stud on the ground end. |
• Scalpel Blade (FDA Code: GES / 878.4800) A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892. |
• Self Adhesive Strips (FDA Code: FPX / 880.5240) |
• Skin Closure Adhesive Strips (FDA Code: FPX / 880.5240) |
• Stainless Steel Blood Lancets |
• Sterile Absorbent Tipped Applicator (FDA Code: KXG / 880.6025) |
• Surgical Caps (FDA Code: FYF / 878.4040) |
• Surgical Masks (FDA Code: FXX / 878.4040) |
• Tongue Depressors (FDA Code: FMA / 880.6230) |
• Transfer Aid (FDA Code: IKX / 890.5050) A daily activity assist device is a modified adaptor or utensil (e.g., a dressing, grooming, recreational activity, transfer, eating, or homemaking aid) that is intended for medical purposes to assist a patient to perform a specific function. |
• Transfer Aid for Disabled/Handicapped (FDA Code: IKX / 890.5050) |
• Urinals (FDA Code: FNP / 880.6730) A body waste receptacle is a device intended for medical purposes that is not attached to the body and that is used to collect the body wastes of a bed patient. |
• Wheelchair Accessories (FDA Code: KNO / 890.3910) A wheelchair accessory is a device intended for medical purposes that is sold separately from a wheelchair and is intended to meet the specific needs of a patient who uses a wheelchair. Examples of wheelchair accessories include but are not limited to the following: armboard, lapboard, pusher cuff, crutch and cane holder, overhead suspension sling, head and trunk support, and blanket and leg rest strap. |
• Wheelchair Anti-Tip Device (FDA Code: IMR / 890.3920) A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops. |
• Wheelchair Cushions (FDA Code: IMP / 890.3920) |
• X-Ray Detectable Gauze (FDA Code: GDY / 878.4450) Nonabsorbable gauze for internal use is a device made of an open mesh fabric intended to be used inside the body or a surgical incision or applied to internal organs or structures, to control bleeding, absorb fluid, or protect organs or structures from abrasion, drying, or contamination. The device is woven from material made of not less than 50 percent by mass cotton, cellulose, or a simple chemical derivative of cellulose, and contains x-ray detectable elements. |