Device product

Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X

Z-1499-2026

August 13, 2025

Class III

Product summary

Firm: Penner Patient Care, Inc.
Event: Event 98396
Status: Ongoing
Classification: Class III
Quantity: 21 units
Official record key: device-enforcement:Z-1499-2026

Official wording

Reason: The device does not bear a unique device identifier.

Code information: UDI-DI: 0085007365400; Serial Numbers: 06020315401 08010223607 04205543401 05246707501 05246707502 02195222101 11216213301 09185118801 10216206001 10216206002 11216222201 11216222202 05246717201 02195236901 11195422801 01246647601 01246656501 04205544901 12205685701 09236590301 11195432401

Distribution pattern: US Nationwide distribution.

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

The device does not bear a unique device identifier.