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Restraint Accessories

by J. T. Posey Co. 510(k)

Active United States

510(k) K963436

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK963436 Date22 Nov 1996ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

22 recalls · FDA

  • 22 recalls, same reason

    • Terminated Z-2257-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2272-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2273-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2265-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2271-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2275-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2255-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2270-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2254-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2256-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2262-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2269-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2274-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2267-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2263-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2264-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2258-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2268-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2259-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2266-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2260-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009
    • Terminated Z-2261-2009 FDA Unclassified (pre-2012) initiated 20 Apr 2009

    Posey has initiated a recall on certain Posey product units which were manufactured using an incorrect key lock buckle. The intended use of these products is to limit a patient's movement to the extent necessary for treatment, examination or protection of the patient or others.

Specification

510(k)

510(k) Number
FDA Product Code
FMQ
Device Class
Class I
Regulation
21 CFR Part 880.6760
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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