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Bellyboard, Sbrt Accessories

by Medtec Inc. Dba Civco Medical Solutions

510(k) K121545

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK121545 Date8 Jun 2012ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0803-2014 FDA Class II initiated 25 Oct 2013 on shared 510(k) K121545
    • Terminated Z-0802-2014 FDA Class II initiated 25 Oct 2013 on shared 510(k) K121545

    Scales adhered to the product may be misaligned from the zero reference such that one side will not match the other.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
LNH
Device Class
Class II
Regulation
21 CFR Part 892.1000
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Other devices from Med-Tec, Inc. D/B/A Civco Medical Solutions