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Hcmi X-Ray High Requency Chiropractic Radiographic

by Health Care Mfg., Inc.

510(k) K022737

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK022737 Date22 Oct 2002ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0729-03 FDA Unclassified (pre-2012) initiated 15 May 2003

    Required labeling (certification and manufacturer's label) was missing from the Operator Control Panels

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  • Withdrawn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
KPR
Device Class
Class II
Regulation
21 CFR Part 892.1680
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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