FDA product code LBG: Device, Fluidized Therapy, Dry Heat
LBG is the FDA product code for device, fluidized therapy, dry heat. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel. FDA has cleared 1 510(k) submission under LBG. The average 510(k) review took 36 days (median 36).
Classification
| Field | Value |
|---|---|
| Device name | Device, Fluidized Therapy, Dry Heat |
| Device class | Class II |
| Regulation | 21 CFR 890.5500 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every LBG clearance
Top LBG applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Electronic Energy, Inc. | 1 | 1984-01-13 |
Most recent LBG clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K834293 | Electronic Energy, Inc. | ELECTRONIC CELL ENERGIZER | 1984-01-13 | 36 |
Recalls for LBG devices
openFDA lists no recalls for product code LBG.
Frequently asked questions
What is FDA product code LBG?
LBG is the FDA product code for device, fluidized therapy, dry heat. It is a Class II device, regulated under 21 CFR 890.5500 and reviewed by the Physical Medicine panel.
What device class is LBG?
Class II, regulation 21 CFR 890.5500. Typical premarket route: 510(k).
How long does a 510(k) take for product code LBG?
Across 1 cleared submissions the average was 36 days from receipt to decision (median 36).
Which companies have the most LBG clearances?
Electronic Energy, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LBG
- Run a recall and safety report across every LBG manufacturer
- Watch product code LBG 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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