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PRO-2000 Low Air Loss Therapy Bed

by Ch Administration, Inc.

510(k) K926403

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 NumberK926403 Date30 Jul 1993ClearedStatusActive

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  • Withdrawn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, 25 Sep 2026

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

The Pro-2000 Low Air Loss Therapy Bed is a mattress, air flotation, alternating pressure device. It is designed to provide low air loss therapy. The device is classified as a general hospital device.

The Pro-2000 Low Air Loss Therapy Bed is supplied with FDA 510(k) clearance, K926403. It is regulated under regulation number 880.5550 and product code FNM. The device is intended for use in a general hospital setting.

Other devices from Ch Administration, Inc.

Questions

AI-generated answers, 25 Sep 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 Pro-2000 Low Air Loss Therapy Bed used for?

    The Pro-2000 is designed to provide low air loss therapy, typically used in a general hospital setting to support patient care and comfort.

  • Is the Pro-2000 Low Air Loss Therapy Bed supplied sterile?

    The device data does not specify sterility, it is regulated under 880.5550 and has FDA 510(k) clearance, K926403.

  • What are the regulatory approvals for the Pro-2000 Low Air Loss Therapy Bed?

    The Pro-2000 has FDA 510(k) clearance, K926403, and is regulated under regulation number 880.5550 with product code FNM.