LSB — Unit, Fluidotherapy Class II
FDA product code LSB covers "Unit, Fluidotherapy", a Class II medical device regulated under 21 CFR 890.5100. Submissions are reviewed by the Physical Medicine panel. At least 4 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LSB
- Device Class
- Class II
- Regulation Number
- 890.5100
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011768 | thermo-electric | THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 | August 3, 2001 |
| K011243 | chattanooga group | CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 | July 6, 2001 |
| K896817 | henley intl | MODEL T11 FLUIDOTHERAPY UNIT | January 18, 1991 |
| K871802 | henley intl | MODEL K210 AND K211 FLUIDOTHERAPY UNITS | September 4, 1987 |