Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
Bed, Therapeutic, AC-Powered, Adjustable, Home-Use is an electrically powered adjustable bed intended for therapeutic use in the home setting, designed to assist patients with limited mobility, post-surgical recovery, or chronic conditions by allowing repositioning of the head, foot, and overall height. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLI, regulated under 21 CFR 880.5100, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LLI
- Device Class
- FDA class 2
- Regulation Number
- 880.5100
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 2 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K022387 | CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC | Sep 19, 2002 | Substantially Equivalent | Craftmatic Organization, Inc. |
| K840787 | CRAFTMATIC ELECTRIC ADJUSTABLE BED | Jun 13, 1984 | Substantially Equivalent | Contour, Inc. |
FEI Numbers
This FDA classification entry is associated with 43 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 43 registration numbers. Click on an entry to view related FDA registrations.