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Hp-1 (Healthpax)

by Healthdirections, Inc.

510(k) K883812

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 11 Oct 2026. What this means

Regulatory status

as of registry sync 11 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK883812 Date28 Nov 1988ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1242-2007 FDA Unclassified (pre-2012) initiated 19 Jul 2007 on shared 510(k) K883812

    Peak voltage test result not in acceptable limits.

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  • Withdrawn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
QJQ
Device Class
Class II
Regulation
21 CFR Part 882.5800
Advisory Committee
Neurology
FDA Decision
SESE Substantially Equivalent