ILM — Bath, Sitz, Powered Class II

FDA Device Classification

FDA product code ILM covers "Bath, Sitz, Powered", a Class II medical device regulated under 21 CFR 890.5100. Submissions are reviewed by the Physical Medicine panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
ILM
Device Class
Class II
Regulation Number
890.5100
Submission Type
Review Panel
PM
Medical Specialty
Physical Medicine
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K953796keith productsBANKS HYDRO-THERAPY CHAIRApril 1, 1996
K823327wall manufacturerPORTABLE SHOWER BATHDecember 7, 1982