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510(k) K022387

CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC by Craftmatic Organization, Inc. — Product Code LLI

K022387 is an FDA 510(k) premarket notification submitted by Craftmatic Organization, Inc. for the device "CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC". The FDA issued a decision of Substantially Equivalent on September 19, 2002. The device falls under product code LLI (Bed, Therapeutic, Ac-Powered, Adjustable Home-Use), a Class II device regulated under 21 CFR 880.5100.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 19, 2002
Date Received
July 23, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Device Class
Class II
Regulation Number
880.5100
Review Panel
HO
Submission Type

Other clearances for product code LLI

  • K840787 — CRAFTMATIC ELECTRIC ADJUSTABLE BED (June 13, 1984)

FDA data resources