The following data is part of a premarket notification filed by Craftmatic Organization, Inc. with the FDA for Craftmatic Adjustable Beds With Optional Heat & Massage, Models Craftmatic Monaco, I, Ii, Iii & Classic.
| Device ID | K022387 |
| 510k Number | K022387 |
| Device Name: | CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC |
| Classification | Bed, Therapeutic, Ac-powered, Adjustable Home-use |
| Applicant | CRAFTMATIC ORGANIZATION, INC. 2550 M STREET, N.W. Washington, DC 20037 |
| Contact | Paul D Rubin |
| Correspondent | Paul D Rubin CRAFTMATIC ORGANIZATION, INC. 2550 M STREET, N.W. Washington, DC 20037 |
| Product Code | LLI |
| CFR Regulation Number | 880.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-07-23 |
| Decision Date | 2002-09-19 |
| Summary: | summary |