FDA product code LLI: Bed, Therapeutic, Ac-Powered, Adjustable Home-Use
LLI is the FDA product code for bed, therapeutic, ac-powered, adjustable home-use. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel. FDA has cleared 2 510(k) submissions under LLI, from 2 different applicants. The average 510(k) review took 102 days (median 102). FDA has posted 19 recalls for LLI devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Bed, Therapeutic, Ac-Powered, Adjustable Home-Use |
| Device class | Class II |
| Regulation | 21 CFR 880.5100 |
| Review panel | HO — General Hospital |
| Medical specialty | General Hospital |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LLI clearance
Top LLI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Craftmatic Organization, Inc. | 1 | 2002-09-19 |
| Contour, Inc. | 1 | 1984-06-13 |
Most recent LLI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K022387 | Craftmatic Organization, Inc. | CRAFTMATIC ADJUSTABLE BEDS WITH OPTIONAL HEAT & MASSAGE, MODELS CRAFTMATIC MONACO, I, II, III & CLASSIC | 2002-09-19 | 58 |
| K840787 | Contour, Inc. | CRAFTMATIC ELECTRIC ADJUSTABLE BED | 1984-06-13 | 145 |
Recalls for LLI devices
19 product recalls in 10 recall events; 8 initiated in the last five years and 10 still open. Most recent: 2025-11-26.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2022 | 1 |
| 2024 | 1 |
| 2025 | 6 |
Frequently asked questions
What is FDA product code LLI?
LLI is the FDA product code for bed, therapeutic, ac-powered, adjustable home-use. It is a Class II device, regulated under 21 CFR 880.5100 and reviewed by the General Hospital panel.
What device class is LLI?
Class II, regulation 21 CFR 880.5100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LLI?
Across 2 cleared submissions the average was 102 days from receipt to decision (median 102).
Which companies have the most LLI clearances?
Craftmatic Organization, Inc. (1); Contour, Inc. (1).
Have LLI devices been recalled?
Yes: 19 product recalls across 10 recall events; the most recent began 2025-11-26.
Next steps
- Run an FDA pathway report with predicate devices for product code LLI
- Run a recall and safety report across every LLI manufacturer
- Watch product code LLI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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