Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

PERSONAL SITZ BATH KIT

K-Number: K800958 · 1980-05-02

ApplicantThe Healthcare Group Laboratories, Inc.
Decision Date1980-05-02
Product CodeKTC
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

PERSONAL SITZ BATH KIT is the device name listed in this FDA 510(k) record. The listed applicant is The Healthcare Group Laboratories, Inc.. It received FDA 510(k) clearance on 1980-05-02 under 510(k) number K800958. The device is classified under product code KTC. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PERSONAL SITZ BATH KIT?

PERSONAL SITZ BATH KIT is a medical device that received FDA 510(k) clearance on 1980-05-02. The listed applicant is The Healthcare Group Laboratories, Inc.. The 510(k) number is K800958.

When did PERSONAL SITZ BATH KIT receive FDA 510(k) clearance?

PERSONAL SITZ BATH KIT received FDA 510(k) clearance on 1980-05-02, under 510(k) number K800958.

Who is the listed applicant for PERSONAL SITZ BATH KIT?

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

What is the FDA product code for PERSONAL SITZ BATH KIT?

The FDA product code for PERSONAL SITZ BATH KIT is KTC.

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 The Healthcare Group Laboratories, 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.

K850035EMPTY SOLUTION TRANSFER CONTAINERK842170EMPTY SOLUTION TRANSFER CONTAINERK842091DISPOS. ACU-CUT SOFT TISSUE BIOPSYK840742RIGHT ATRIAL CATHETERK830299SOLUTION TRANSFER CONTAINERK822307ADHESIVE SPRAY #4050-4060

View all 29 devices →

Related Devices (Code: KTC)

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.

K912179THE SPRITZ BATHThe Spritz Co.K890085SIT-N-BATHE SITZ BATHDrummond Industries, Inc.K862600SITZ BATHW. C. Green, D.D.S.K851309ABCO PLASTIC UTENSILSAbco Dealers, Inc.K841711MAC LEE SITZ BATHMac Lee Medical ProductsK831762SITZ BATH, SINGLE PATIENT USE #8100Lsl Industries, 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.

↑