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|• (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.
|• (FDA Code: FNM / 880.5550)|
An alternating pressure air flotation mattress is a device intended for medical purposes that consists of a mattress with multiple air cells that can be filled and emptied in an alternating pattern by an associated control unit to provide regular, frequent, and automatic changes in the distribution of body pressure. The device is used to prevent and treat decubitus ulcers (bed sores).
|• (FDA Code: FNM / 880.5550)|
|• (FDA Code: CAE / 868.5110)|
An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.
|• (FDA Code: FOB / 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.
|• (FDA Code: FMK / 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.
|• (FDA Code: KIA / 880.6185)|
A cast cover is a device intended for medical purposes that is made of waterproof material and placed over a cast to protect it from getting wet during a shower or a bath.
|• (FDA Code: IPG / 890.3025)|
A prosthetic and orthotic accessory is a device intended for medical purposes to support, protect, or aid in the use of a cast, orthosis (brace), or prosthesis. Examples of prosthetic and orthotic accessories include the following: A pelvic support band and belt, a cast shoe, a cast bandage, a limb cover, a prosthesis alignment device, a postsurgical pylon, a transverse rotator, and a temporary training splint.
|• (FDA Code: IQK / 890.3490)|
A truncal orthosis is a device intended for medical purposes to support or to immobilize fractures, strains, or sprains of the neck or trunk of the body. Examples of truncal orthoses are the following: Abdominal, cervical, cervical-thoracic, lumbar, lumbo-sacral, rib fracture, sacroiliac, and thoracic orthoses and clavicle splints.
|• (FDA Code: FLK / 880.2920)|
A clinical mercury thermometer is a device used to measure oral, rectal, or axillary (armpit) body temperature using the thermal expansion of mercury.
|• (FDA Code: MHW / 880.5075)|
An elastic bandage is a device consisting of either a long flat strip or a tube of elasticized material that is used to support and compress a part of a patient's body.
|• (FDA Code: KPN / 876.2040)|
An enuresis alarm is a device intended for use in treatment of bedwetting. Through an electrical trigger mechanism, the device sounds an alarm when a small quantity of urine is detected on a sensing pad. This generic type of device includes conditioned response enuresis alarms.
|• (FDA Code: FLL / 880.2910)|
A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.
|• (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.
|• (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.
|• (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.
|• (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.
|• (FDA Code: JOK / 880.6820)|
Medical disposable scissors are disposable type general cutting devices intended for medical purposes. This generic type of device does not include surgical scissors.
|• (FDA Code: ILD / 890.5050)|
|• (FDA Code: ILC / 890.5050)|
|• (FDA Code: FQM / 880.5075)|
|• (FDA Code: KIC / 890.3175)|
A flotation cushion is a device intended for medical purposes that is made of plastic, rubber, or other type of covering, that is filled with water, air, gel, mud, or any other substance allowing a flotation media, used on a seat to lessen the likelihood of skin ulcers.
|• (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.
|• (FDA Code: 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.
|• (FDA Code: EYQ / 876.5920)|
A protective garment for incontinence is a device that consists of absorbent padding and a fluid barrier and that is intended to protect an incontinent patient's garment from the patient's excreta. This generic type of device does not include diapers for infants.
|• (FDA Code: FMA / 880.6230)|
|• (FDA Code: FMA / 880.6230)|
|• (FDA Code: LYY / 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.
|• (FDA Code: KPD / 880.2200)|
A liquid crystal forehead temperature strip is a device applied to the forehead that is used to indicate the presence or absence of fever, or to monitor body temperature changes. The device displays the color changes of heat sensitive liquid crystals corresponding to the variation in the surface temperature of the skin. The liquid crystals, which are cholesteric esters, are sealed in plastic.
|• (FDA Code: IQE / 890.3490)|
|• (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.
|• (FDA Code: LDE / 870.1875)|
A manual stethoscope is a mechanical device used to project the sounds associated with the heart, arteries, and veins and other internal organs.
|• (FDA Code: FMW / 880.6190)|
A mattress cover for medical purposes is a device intended for medical purposes that is used to protect a mattress. It may be electrically conductive or contain a germicide.
|• (FDA Code: INN / 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.
|• (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.
|• (FDA Code: FRL / 880.5300)|
A medical absorbent fiber is a device intended for medical purposes that is made from cotton or synthetic fiber in the shape of a ball or a pad and that is used for applying medication to, or absorbing small amounts of body fluids from, a patient's body surface. Absorbent fibers intended solely for cosmetic purposes are not included in this generic device category.
|• (FDA Code: IMA / 890.5730)|
A moist heat pack is a device intended for medical purposes that consists of silica gel in a fabric container used to retain an elevated temperature and that provides moist heat therapy for body surfaces.
|• (FDA Code: DXN / 870.1130)|
A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.
|• (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.
|• (FDA Code: HIB / 884.4530)|
An obstetric-gynecologic specialized manual instrument is one of a group of devices used during obstetric-gynecologic procedures to perform manipulative diagnostic and surgical functions (e.g., dilating, grasping, measuring, and scraping), where structural integrity is the chief criterion of device performance. This type of device consists of the following: