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Penner Patient Care, INC: FDA-registered device maker in Aurora, NE, United States, 1 510(k) clearance

Name: Penner Patient Care, INC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Penner Patient Care, INC is registered with the FDA (registration 1922538) in Aurora, NE, United States. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 5, 2004. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch Penner Patient Care, INC

FDA registration number: 1922538
Address: 101 Grant St, Aurora, NE, United States, 68818
Owner or operator: Penner Patient Care, INC (9041224)
Roles: Manufacturer
First device listed: November 26, 2007
Registered through: 2026
Brand names listed: PACIFIC

Devices it lists

Device	Product code	Class	Role	Source
Bath, Hydro-Massage	ILJ	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
April 5, 2004	K040772	PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM	ILJ	Substantially Equivalent	Penner Manufacturing, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 13, 2025	98396	Class III	Ongoing	Penner Pacific Bathing Spa, Model Numbers 350010-1, 350000-2, 350010-X	The device does not bear a unique device identifier.	accessdata.fda.gov
January 30, 2015	70151	Class II	Terminated	Penner Patient Stretcher/Transfer Lift System Models 391000-1 and 392000-1 The Pacific Stretcher/Transfer Lift is used with Whirlpool or Aqua-Aire (air bubbling) bathing system intended for use in nursing homes, hospital	If the patient sits on either wing, not squarely on the center section of the Stretcher Lift, tipping and injury to the operator or patient could result. The device manual was updated with an additional warning statement.	accessdata.fda.gov
January 19, 2009	56977	Not yet classified	Terminated	Penner Manufacturing Patient Transfer/Lift System, Cascade Transfer, Models 380000-1 (white) and 380000-2 (gray). The firm name on the label is Penner Manufacturing Inc., Aurora, NE. For use with bathing systems in nursi	Incomplete weld on the pillar mounting bracket	accessdata.fda.gov

Compare with other makers

All makers of Bath, Hydro-Massage

Updated March 9, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.