MIGHTY AIR

K974319 · Wheelchairs of Kansas · FNM · Jan 22, 1998 · General Hospital

Device Facts

• Record ID: K974319
• Device Name: MIGHTY AIR
• Applicant: Wheelchairs of Kansas
• Product Code: FNM · General Hospital
• Decision Date: Jan 22, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Mighty*Air is used to help prevent and treat pressure ulcers.

Device Story

Mighty*Air is a pressure-relieving support device designed to prevent and treat pressure ulcers. It functions by providing a surface that redistributes pressure to reduce tissue interface pressure. Used in clinical or home settings, it is operated by patients or caregivers. The device output is a supportive surface that aids in skin integrity maintenance, directly impacting clinical management of pressure sores and improving patient outcomes by reducing risk of tissue breakdown.

Clinical Evidence

No clinical data provided; substantial equivalence determination based on device description and intended use.

Technological Characteristics

Pressure-relieving support surface; mechanical design for pressure redistribution. No software, electronic components, or specific material standards mentioned.

Indications for Use

Indicated for the prevention and treatment of pressure ulcers in patients requiring pressure relief support.

Regulatory Classification

Identification

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).

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Lee Frickey President Wheelchairs of Kansas P.O. Box 320 204 W. 2nd Street Ellis, Kansas 67637

JAN 22 1998

K974319 Re : Mighty Air Trade Name: Requlatory Class: II Product Code: FNM Dated: November 10, 1997 Received: November 17, 1997

Dear Mr. Frickey:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A ... .... substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does

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not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its internet address "http://www.fla.gov/cdrh/dsmamain.html".

Sincerely yours

Timothy A. Ulatowski

Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K974319

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510 (k) NUMBER (IF KNOWN) : __________________________________________________________________________________________________________________________________________________

DEVICE NAME: Mighty *Air

INDICATIONS FOR USE:

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The Mighty*Air is used to help prevent and treat pressure ulcers.

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Concurrence of CDRH, Office of Device Evaluation (ODE)
Adrance Cuesenti
(Division Sign Off)

(Division Sign-Off) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Division of Dental, Infection Contrel; and General Hospital Device 74517 Over-The-Counter-Use Eretchamberon Use OR (Optional Format 1-2-96) (Per 21 CFR 801.109)