REST MATTRESS

K971568 · Rest Mattress · FNM · Jul 18, 1997 · General Hospital

Device Facts

• Record ID: K971568
• Device Name: REST MATTRESS
• Applicant: Rest Mattress
• Product Code: FNM · General Hospital
• Decision Date: Jul 18, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.

Device Story

REST Mattress provides alternating pressure support to prevent and manage decubitus ulcers. Device functions as a support surface for patients at high risk of pressure sores. Operates by cycling pressure to redistribute weight and reduce interface pressure on skin. Used in clinical or home settings to assist in patient care and pressure ulcer prevention. Healthcare providers or caregivers utilize the mattress to support patients with limited mobility or those bedridden for extended periods. Benefits include reduction of tissue ischemia and prevention of skin breakdown.

Clinical Evidence

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

Technological Characteristics

Alternating pressure support surface; mechanical design for pressure redistribution. Specific materials and standards not disclosed in the provided text.

Indications for Use

Indicated for patients highly susceptible to decubitus ulcers for the prevention and management of pressure sores.

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. Yoav Gershoni Rest Mattress 19636 Club House Road, Suite 120 -Gaithersburg, Maryland 20879 T

## JUL 18 1997

K971568 Re : REST Mattress Trade Name: Requlatory Class: II Product Code: FNM Dated: April 29,1 997 April 29, 1997 Received:

Dear Mr. Gershoni:

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, Druq, 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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Paqe 2 - Mr. Gershoni

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 qeneral 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.qov/cdrh/dsmamain.html".

Sincerely yours,

L. Whitmarsh

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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K97/568

## XII. Statement of Indications For Use

The REST Mattress is indicated for all patients highly susceptible to decubitus ulcers. The REST Mattress provides alternating pressure support for the prevention and management of these sores.

Your D.
Signature

Signature

Your Gerstein
Name

6/18/97

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**Date**

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Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) (Division of Dental, Infection Control Divisioneral Hospital Devic 1 - 1 Number _ 1 9 2 /

Preseription Use (Pcr 21 CFR 801.109)

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Over-The-Counter Use Or (Optional Format 1-2-96

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