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LLI — Bed, Therapeutic, Ac-Powered, Adjustable Home-Use Class II

FDA Device Classification

FDA product code LLI covers "Bed, Therapeutic, Ac-Powered, Adjustable Home-Use", a Class II medical device regulated under 21 CFR 880.5100. Submissions are reviewed by the General Hospital panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
LLI
Device Class
Class II
Regulation Number
880.5100
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K022387craftmatic organizationCRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACSeptember 19, 2002
K840787contourCRAFTMATIC ELECTRIC ADJUSTABLE BEDJune 13, 1984

FDA data resources