Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic
FDA 510(k) K022387 · Craftmatic Organization, Inc.
510(k) numberK022387
Submission
- Device name
- Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic
- Applicant
- Craftmatic Organization, Inc.
Washington, DC, US - Received
- July 23, 2002
- Decision date
- September 19, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LLI – Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5100
- Specialty
- General Hospital
Other 510(k)s with product code LLI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K840787 | Craftmatic Electric Adjustable BedLLI · Traditional | Contour, Inc. | 06/13/1984SE |
Questions and answers
When was Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic cleared by the FDA?
Craftmatic Adjustable Beds with Optional Heat & Massage, Models Craftmatic Monaco, I, II, III & Classic (K022387) received a 510(k) decision of Substantially Equivalent on September 19, 2002, 58 days after the submission was received.
What is the product code of K022387?
The FDA product code is LLI – Bed, Therapeutic, Ac-Powered, Adjustable Home-Use, a Class II (moderate risk) device regulated under 21 CFR 880.5100.