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FDA 510(k)

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM

K-Number: K040772 · 2004-04-05

ApplicantPenner Manufacturing, Inc.
Decision Date2004-04-05
Product CodeILJ
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Penner Manufacturing, Inc.. It received FDA 510(k) clearance on 2004-04-05 under 510(k) number K040772. The device is classified under product code ILJ. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM?

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM is a medical device that received FDA 510(k) clearance on 2004-04-05. The listed applicant is Penner Manufacturing, Inc.. The 510(k) number is K040772.

When did PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM receive FDA 510(k) clearance?

PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM received FDA 510(k) clearance on 2004-04-05, under 510(k) number K040772.

Who is the listed applicant for PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM?

The FDA 510(k) record lists Penner Manufacturing, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM?

The FDA product code for PACIFIC RECUMBENT HEIGHT-ADJUSTABLE BATH SYSTEM is ILJ.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Penner Manufacturing, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K012057CASCADE BATH, MODEL 6900K012061SUPERIOR BATH, MODEL 6300

Related Devices (Code: ILJ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K110994PARKER 500Arjohuntleigh, Inc.K082951IMMERSION HYDROBATHArjo Hospital Equipment ABK052479MBATH 1000 (60)Enneking Medical, Inc.K012061SUPERIOR BATH, MODEL 6300Penner Manufacturing, Inc.K012057CASCADE BATH, MODEL 6900Penner Manufacturing, Inc.K001079RECUMBENT BATHING SYSTEMS, RHAPSODY AND PRIMOArjo, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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