Profile: Zhongshan A&e Machinery Industry Co., Ltd. manufactures beds, chairs and other products for patient comfort. Our products include canes, crutch, walkers, blood-donator chairs, wheel chairs, ac-powered beds, manual beds, patient lifes, traction head halters, transfer aids, suction cups, mechanical walkers, adjustable chairs, transfer aids, safety walk canes and other products.
FDA Registration Number: 3003781173
US Agent: Kevin Walls / Regulatory Insight, Inc.
Phone: +1-(720)-962-5412 Fax: +1-(720)-962-5413 E-Mail:
40 Products/Services (Click for related suppliers)
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• Adjustable Hospital AC-Powered Beds (FDA Code: FNL / 880.5100) An AC-powered adjustable hospital bed is a device intended for medical purposes that consists of a bed with a built-in electric motor and remote controls that can be operated by the patient to adjust the height and surface contour of the bed. The device includes movable and latchable side rails. |
• Blood Donor Chair (FDA Code: FML / 880.6140) A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination. |
• Chair with Casters (FDA Code: INM / 890.3100) A mechanical chair is a manually operated device intended for medical purposes that is used to assist a disabled person in performing an activity that the person would otherwise find difficult to do or be unable to do. Examples of mechanical chairs include the following: A chair with an elevating seat used to raise a person from a sitting position to a standing position and a chair with casters used by a person to move from one place to another while sitting. |
• Crutch (FDA Code: IPR / 890.3150) A crutch is a device intended for medical purposes for use by disabled persons to provide minimal to moderate weight support while walking. |
• Crutch and Walker Cane Tips (FDA Code: INP / 890.3790) Cane, crutch, and walker tips and pads are rubber (or rubber substitute) device accessories intended for medical purposes that are applied to the ground end of mobility aids to prevent skidding or that are applied to the body contact area of the device for comfort or as an aid in using an ambulatory assist device. |
• Direct Patient Interface Nebulizer (FDA Code: CAF / 868.5630) A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device. |
• Disabled/Handicapped Hygiene Adaptor (FDA Code: ILS / 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. |
• Disabled/Handicapped Manual Wheelchair (FDA Code: IOR / 890.3850) A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. |
• Disabled/Handicapped Motorized 3-Wheeled Vehicle (FDA Code: INI / 890.3800) A motorized three-wheeled vehicle is a gasoline-fueled or battery-powered device intended for medical purposes that is used for outside transportation by disabled persons. |
• Gas Cylinder Pressure Regulator (FDA Code: CAN / 868.2700) A pressure regulator is a device, often called a pressure-reducing valve, that is intended for medical purposes and that is used to convert a medical gas pressure from a high variable pressure to a lower, more constant working pressure. This device includes mechanical oxygen regulators. |
• General Surgical Manual Instrument (FDA Code: MDM / 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. |
• Handicapped Cane (FDA Code: IPS / 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. |
• Infusion Stand (FDA Code: FOX / 880.6990) The infusion stand is a stationary or movable stand intended to hold infusion liquids, infusion accessories, and other medical devices. |
• Manual Beds (FDA Code: FNJ / 880.5120) A manual adjustable hospital bed is a device intended for medical purposes that consists of a bed with a manual mechanism operated by an attendant to adjust the height and surface contour of the bed. The device includes movable and latchable side rails. |
• Manual/Powered Portable Aspiration Pump (FDA Code: BTA / 878.4780) A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter. |
• Mechanical Adjustable Chair (FDA Code: INN / 890.3100) |
• Mechanical Walker (FDA Code: ITJ / 890.3825) A mechanical walker is a four-legged device with a metal frame intended for medical purposes to provide moderate weight support while walking. It is used by disabled persons who lack strength, good balance, or endurance. |
• Mechanical Wheelchair (FDA Code: IOR / 890.3850) |
• Medical Chair and Table (FDA Code: KMN / 880.6140) |
• Non AC-Powered Patient Lift (FDA Code: FSA / 880.5510) A non-AC-powered patient lift is a hydraulic, battery, or mechanically powered device, either fixed or mobile, used to lift and transport a patient in the horizontal or other required position from one place to another, as from a bed to a bath. The device includes straps and a sling to support the patient. |
• Non-Electrical Surgical Chair (FDA Code: FZK / 878.4950) A manual operating table and accessories and a manual operating chair and accessories are nonpowered devices, usually with movable components, intended to be used to support a patient during diagnostic examinations or surgical procedures. |
• Non-Measuring Exerciser (FDA Code: ION / 890.5370) Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle. |
• 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. |
• Portable Oxygen Generator (FDA Code: CAW / 868.5440) A portable oxygen generator is a device that is intended to release oxygen for respiratory therapy by means of either a chemical reaction or physical means (e.g., a molecular sieve). |
• Powered Wheelchair (FDA Code: ITI / 890.3860) A powered wheelchair is a battery-operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position. |
• Pressure Tubing and Accessories (FDA Code: BYX / 868.5860) Pressure tubing and accessories are flexible or rigid devices intended to deliver pressurized medical gases. |
• Safety Walk Cane (FDA Code: KHY / 890.3075) |
• Table Operating Room Accessories (FDA Code: FWZ / 878.4950) |
• Traction Head Halter (FDA Code: HSS / 888.5890) A noninvasive traction component is a device, such as a head halter, pelvic belt, or a traction splint, that does not penetrate the skin and is intended to assist in connecting a patient to a traction apparatus so that a therapeutic pulling force may be applied to the patient's body. |
• Transfer Aid (FDA Code: IKX / 890.5050) |
• Transfer Aid for Disabled/Handicapped (FDA Code: IKX / 890.5050) |
• 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 Armrest (FDA Code: IML / 890.3920) |
• Wheelchair Belt (FDA Code: IQB / 890.3920) |
• Wheelchair Component (FDA Code: KNN / 890.3920) |
• Wheelchair Cushions (FDA Code: IMP / 890.3920) |
• Wheelchair Extension Brake (FDA Code: IMW / 890.3920) |
• Wheelchair Footrests (FDA Code: IMM / 890.3920) |
• Wheelchair Handrim (FDA Code: IMO / 890.3920) |