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Bioflex Garments, Assorted Models

by Bioflex, Inc.

510(k) K944543

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

4 closed

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 NumberK944543 Date19 Jul 1995ClearedStatusActive

Recalls

4 recalls · FDA

  • 4 recalls, same reason

    • Terminated Z-2898-2011 FDA Unclassified (pre-2012) initiated 27 May 2011
    • Terminated Z-2900-2011 FDA Unclassified (pre-2012) initiated 27 May 2011
    • Terminated Z-2901-2011 FDA Unclassified (pre-2012) initiated 27 May 2011
    • Terminated Z-2899-2011 FDA Unclassified (pre-2012) initiated 27 May 2011

    Premature Device Failure : Failure of the electrode sites to conduct and provide muscle stimulation due to silver fabric component failure.

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  • Withdrawn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
GXY
Device Class
Class II
Regulation
21 CFR Part 882.1320
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent