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Psi Bands

by Psi Health Solutions, Inc.

510(k) K070766

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK070766 Date26 Jul 2007ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1821-2008 FDA Unclassified (pre-2012) initiated 26 Apr 2007

    Product was marketed before its 510(k) application cleared.

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  • Withdrawn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
MVV
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent