NURSE'S AID PATIENT ROTATION SYSTEM

K973624 · Air Med Assist Products · IOQ · Jan 21, 1998 · Physical Medicine

Device Facts

• Record ID: K973624
• Device Name: NURSE'S AID PATIENT ROTATION SYSTEM
• Applicant: Air Med Assist Products
• Product Code: IOQ · Physical Medicine
• Decision Date: Jan 21, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5170
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.

Device Story

Air-flotation, alternating pressure mattress system; includes detachable electric pump/compressor and washable/disposable cover. Used in home or clinical settings by patients, nurses, or caregivers. Device provides torso support and rotation via manually-controlled alternating pressure to relieve pressure points. Assists caregivers in shifting patient position to minimize risk of bed sores, embolisms, and complications associated with prolonged immobility. Healthcare providers utilize the system to facilitate patient repositioning and pressure management.

Clinical Evidence

Bench testing only; no clinical data provided. Safety and performance verified via independent laboratory testing for EMC and safety, and adherence to quality system regulations.

Technological Characteristics

Air-flotation mattress with detachable electric pump/compressor. Materials consistent with pre-amendment medical/water-buoyancy industry standards. Manual control for alternating pressure. System includes mattress and cover.

Indications for Use

Indicated for patients requiring assistance with body positioning to prevent bed sores or complications from prolonged immobility. Suitable for use in home or clinical settings by patients or caregivers.

Regulatory Classification

Identification

A powered flotation therapy bed is a device that is equipped with a mattress that contains a large volume of constantly moving water, air, mud, or sand. It is intended for medical purposes to treat or prevent a patient's bedsores, to treat severe or extensive burns, or to aid circulation. The mattress may be electrically heated.

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 § 890.9.

Predicate Devices

• K931594
• K933091

Submission Summary (Full Text)

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## SUMMARY OF SAFETY AND EFFECTIVENE

## JAN 2 1 1998

- 01. DEVICE NAME (Trade, common, and classification): Flotation mattress.
- 02. PREDICATE DEVICE(s): K931594 and K933091 submissions, attached, which were determined to be SE, and several others.
- 03. DESCRIPTION: An air-flotation, alternating pressure mattress, with detachable electric pump/compressor, reuseable, with available washable/disposable mattress cover.
- 04. INTENDED USE: To cushion patient, and provide torso support and rotation with _ pressure-relieving capabilities: to assist a nurse/other care giver in shifting a patient's body position, to minimize possibility of bed sores, embolisims, or other problems which can develop from lying in one position for prolonged periods.
- 05. We believe this submission should be found substantially equivalent by virtue of the following points, expanded upon elsewhere in this submission:
- 5.1. No substantitive change in materials, basic components, or method of manufacture between this device and the predicate; the raw materials/components used have been used in the medical (and water-boyancy) industry on similiar/identical products and for similiar/identical uses since pre-amendment, with no record of any patient problems, adverse reactions;
- 5.2. No change in basic construction;

ﺔ ﻣﻌﻬﺪ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪﺓ ﺍﻟﻤﺘﺤﺪ

- 5.3. The device and its components have been tested by an independent lab for EMC and safety, and will be subjected to inspection/testing at IQA, and during/after manufacture and prior to release to the field: "Suitshasserverokening clease to CHO emergency procedures with large colored/labeled pullatag.
- 5.4. The function and use of this product will be no different than that of the predicate devices, and countless other similiar devices in the marketplace since pre-amendment.
- 06. There are no substantive differences between the products defined in this 510(k) submission and the predicate devices.

Signed: *Dopong B.C. Hara* Dated: *9-19-99*

Tommy B. Haas, CEO/General Manager AIR MED ASSIST PRODUCTS LLC 1488 South State Street, Suite 100 Salt Lake City UT 84115 Phone: [phone]

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Image /page/1/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle-like symbol with three curved lines forming its body and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol. The text is in all caps and is evenly spaced around the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

IAN 21 1998

Mr. Tommy B. Haas · CEO/General Manager Air Med Assist Products LLC 1488 South State Street, Suite 100 Salt Lake City, Utah 84115

Re: K973624 Nurse's Aid Patient Rotation System Regulatory Class: II Product Code: IOQ Dated: January 5, 1998 Received: January 6, 1998

Dear Mr. Haas:

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 of the Act. The general controls provisions 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 regulations affecting your device can be found in the Code of Federal Regulations, 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 action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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 regulations.

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Page 2 - Mr. Tommy B. Haas

This letter will allow you to beqin 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.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

a M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1 ---

510(k) Number (if known): K973624

Device Name:_ Nurse's Aid Patient Rotation System

Indications For Use:

This device is used to provide cushioning, torso support and totation (by manually-controlled alternating pressure) with pressure-relieving capabilities, as well as provide an aid to a nurse or other care-giver, in the home, we read foinical setting, to assist a patient in shifting their body position, to minimize possibility of bed sores, or other problems that can result from lying or sitting in one position for excessive periods of time.

(Revised 01/05/98) ¨¨¨¨¨¨ ¨¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ¨ ´

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|-----------------------------------------|---------|
| Division of General Restorative Devices | |
| 510(k) Number | K973624 |

Prescription Use_XX (Per 21 CFR 801.109)

OR AND/

Over-The-Counter Use XX

(Optional Format 1-2-96)