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Equi-Pise 1000 MRS

by Advanced Air Support Consultancy, Inc.

510(k) K970350

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970350 Date22 Apr 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FNM
Device Class
Class II
Regulation
21 CFR Part 880.5550
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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 EQUI-PISE 1000 MRS is a Class 2 General Hospital device with product code FNM.

It received FDA 510(k) clearance K970350 through the Traditional pathway on April 22, 1997, following an 82-day review. The device is manufactured by Advanced Air Support Consultancy, Inc. and is intended for use in general hospital settings.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the EQUI-PISE 1000 MRS used for?

    The EQUI-PISE 1000 MRS is an alternating pressure air flotation mattress intended for medical purposes in general hospital settings to provide regular, frequent, and automatic changes in body pressure distribution through its multiple air cells that fill and empty in an alternating pattern.

  • How is the EQUI-PISE 1000 MRS supplied and what components does it include?

    The EQUI-PISE 1000 MRS consists of a mattress with multiple air cells and requires an associated control unit to fill and empty those cells in an alternating pattern; the mattress and control unit are supplied together as a system for pressure redistribution therapy.

  • Is the EQUI-PISE 1000 MRS reusable or single-use, and what are its storage requirements?

    The EQUI-PISE 1000 MRS is a reusable general hospital device designed for repeated use in clinical environments; it should be stored in a clean, dry location when not in use, following the manufacturer’s maintenance guidelines for the air cells and control unit.