FDA product code LSB: Unit, Fluidotherapy
LSB is the FDA product code for unit, fluidotherapy. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel. FDA has cleared 4 510(k) submissions under LSB, from 3 different applicants. The average 510(k) review took 165 days (median 96).
Classification
| Field | Value |
|---|---|
| Device name | Unit, Fluidotherapy |
| Device class | Class II |
| Regulation | 21 CFR 890.5100 |
| Review panel | PM — Physical Medicine |
| Medical specialty | Physical Medicine |
| Premarket route | 510(k) |
Compare with all 510(k) review times · Search every LSB clearance
Top LSB applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Henley Intl. | 2 | 1991-01-18 |
| Thermo-Electric Co. | 1 | 2001-08-03 |
| Chattanooga Group, Inc. | 1 | 2001-07-06 |
Most recent LSB clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K011768 | Thermo-Electric Co. | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | 2001-08-03 | 57 |
| K011243 | Chattanooga Group, Inc. | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | 2001-07-06 | 74 |
| K896817 | Henley Intl. | MODEL T11 FLUIDOTHERAPY UNIT | 1991-01-18 | 410 |
| K871802 | Henley Intl. | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | 1987-09-04 | 119 |
Recalls for LSB devices
openFDA lists no recalls for product code LSB.
Frequently asked questions
What is FDA product code LSB?
LSB is the FDA product code for unit, fluidotherapy. It is a Class II device, regulated under 21 CFR 890.5100 and reviewed by the Physical Medicine panel.
What device class is LSB?
Class II, regulation 21 CFR 890.5100. Typical premarket route: 510(k).
How long does a 510(k) take for product code LSB?
Across 4 cleared submissions the average was 165 days from receipt to decision (median 96).
Which companies have the most LSB clearances?
Henley Intl. (2); Thermo-Electric Co. (1); Chattanooga Group, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LSB
- Run a recall and safety report across every LSB manufacturer
- Watch product code LSB 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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