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Clinitron Air Fluidized Support System

by Uhi Corp.

510(k) K813584

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 12 Oct 2026. What this means

Regulatory status

as of registry sync 12 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK813584 Date12 Jan 1982ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1902-2009 FDA Unclassified (pre-2012) initiated 24 Jun 2009

    Incorrectly repaired power cord wires can potentially overheat resulting in smoldering sound foam in the base of the therapy bed.

    • Terminated Z-0989-03 FDA Unclassified (pre-2012) initiated 5 May 2003

    Malfunction of side-rail latching pin coupled with inadequate directions for use.

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  • Withdrawn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
INX
Device Class
Class II
Regulation
21 CFR Part 890.5160
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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