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Pacific Recumbent Height-Adjustable Bath System

by Penner Manufacturing, Inc.

510(k) K040772

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

10 ongoing

This device is named in the recall

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 NumberK040772 Date5 Apr 2004ClearedStatusActive

Recalls

10 recalls · 10 ongoing · FDA

  • 10 recalls, same reason

    • Ongoing Z-1508-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1503-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1504-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1505-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1501-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1506-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1507-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1502-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1499-2026 FDA Class III initiated 13 Aug 2025
    • Ongoing Z-1500-2026 FDA Class III initiated 13 Aug 2025

    The device does not bear a unique device identifier.

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  • Withdrawn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
ILJ
Device Class
Class II
Regulation
21 CFR Part 890.5100
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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