PHYSIO/1000

K974070 · Physio Designs, Inc. · FNM · Jan 6, 1998 · General Hospital

Device Facts

• Record ID: K974070
• Device Name: PHYSIO/1000
• Applicant: Physio Designs, Inc.
• Product Code: FNM · General Hospital
• Decision Date: Jan 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5550
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.

Device Story

Physio/1000 is an alternating pressure mattress system designed to prevent or treat decubitus ulcers. Device operates by cyclically inflating and deflating air cells within the mattress to redistribute patient weight and minimize localized pressure points. Used in clinical or home settings to support patients at risk of or suffering from pressure sores. Healthcare providers or caregivers manage the system to ensure proper pressure cycling. By reducing sustained tissue compression, the device promotes blood flow and aids in ulcer healing.

Clinical Evidence

No clinical data provided; substantial equivalence based on technological characteristics and intended use.

Technological Characteristics

Alternating pressure mattress system; pneumatic inflation/deflation mechanism; electrical power source; designed for pressure redistribution.

Indications for Use

Indicated for the healing of decubitus ulcers in patients requiring pressure relief through the minimization of chronic localized occlusive pressures.

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

JAN - 6 1998

Mr. James Terracciano ·President Physio Designs, Incorporated 11 Arden Lane 11725 Commack, New York

Re : K974070 Physio/1000 Trade Name: Regulatory Class: II Product Code: FNM Dated: November 21, 1997 Received: December 01, 1997

Dear Mr. Terracciano:

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 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 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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## Page 2 - Mr. Terracciano

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 Also, please note the Office of Compliance at [phone]. 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,

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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K974070

## INDICATION FOR USE

510(k) Number:

Device Name:

Indication For Use:

' Per 21 CFR 801.109)

Physio / 1000 Alternating Pressure Mattress System

The intended use of this product is for the healing of Decubitus Ulcers through the minimization of chronic localized occlusive pressures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Dental, Infection Control,
and General Hospital Devices
510(k) Number K974070

Prescription Use ***_***_ OR Over-The-Counter

Over-The-Counter Use ستو

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