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)

COMBI SELF PROPELLED SHOWER COMMODE

K-Number: K040677 · 2004-05-20

Decision Date2004-05-20
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

COMBI SELF PROPELLED SHOWER COMMODE is the device name listed in this FDA 510(k) record. The listed applicant is Kjaerulff Rehabilitation A/S. It received FDA 510(k) clearance on 2004-05-20 under 510(k) number K040677. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMBI SELF PROPELLED SHOWER COMMODE?

COMBI SELF PROPELLED SHOWER COMMODE is a medical device that received FDA 510(k) clearance on 2004-05-20. The listed applicant is Kjaerulff Rehabilitation A/S. The 510(k) number is K040677.

When did COMBI SELF PROPELLED SHOWER COMMODE receive FDA 510(k) clearance?

COMBI SELF PROPELLED SHOWER COMMODE received FDA 510(k) clearance on 2004-05-20, under 510(k) number K040677.

Who is the listed applicant for COMBI SELF PROPELLED SHOWER COMMODE?

The FDA 510(k) record lists Kjaerulff Rehabilitation A/S as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for COMBI SELF PROPELLED SHOWER COMMODE?

The FDA product code for COMBI SELF PROPELLED SHOWER COMMODE is IOR.

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.

Related Devices (Code: IOR)

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.

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.

↑