Skip to content

Air Bed & Flotation Dermagard 800 & 900 Systems

by Biologics Intl., Inc.

510(k) K882229

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 11 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK882229 Date16 Aug 1988ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 11 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  • Withdrawn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
IOQ
Device Class
Class II
Regulation
21 CFR Part 890.5170
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

Other devices from Biologics Intl., Inc.

  • Preg-Tex

    Class II

  • Bi-Aso Slide Test

    Class I

  • Bi-Ra Slide Test

    Class II

  • ANA Latex Slide Test

    Class II

  • Beta-Cell

    Class I

  • Carcino-Cek

    Class I

See all devices from Biologics Intl., Inc. →