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K Number
K040677
Device Name
COMBI SELF PROPELLED SHOWER COMMODE
Manufacturer
KJAERULFF REHABILITATION A/S
Date Cleared
2004-05-20

(66 days)

Product Code
IOR
Regulation Number
890.3850
Type
Traditional
Panel
Physical Medicine
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Self- or attendant operated, self-propelled Shower Commode for use by hospitalised or disabled patients.

Device Description

Not Found

AI/ML Overview

This document is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about acceptance criteria or a study proving that the device meets those criteria. The letter primarily states that the device is substantially equivalent to a predicate device and can be marketed.

Therefore, I cannot provide the requested information.

§ 890.3850 Mechanical wheelchair.

(a)
Identification. A mechanical wheelchair is a manually operated device with wheels that is intended for medical purposes to provide mobility to persons restricted to a sitting position.(b)
Classification. Class I (general controls).