MODEL K210 AND K211 FLUIDOTHERAPY UNITS
FDA 510(k) clearance K871802 · decided 1987-09-04
Clearance details
- K-number
- K871802
- Device name
- MODEL K210 AND K211 FLUIDOTHERAPY UNITS
- Applicant
- Henley Intl.
- Decision
- Substantially Equivalent
- Date received
- 1987-05-08
- Decision date
- 1987-09-04
- Days to decision
- 119 days
- Clearance type
- Traditional
- Product code
- LSB
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERMO-THERAPY, MODELS TT-101, TT-201, AND TT-202 (K011768) | Thermo-Electric Co. | 2001-08-03 |
| CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000 (K011243) | Chattanooga Group, Inc. | 2001-07-06 |
| MODEL T11 FLUIDOTHERAPY UNIT (K896817) | Henley Intl. | 1991-01-18 |
Recalls involving this device
No recalls on record reference this clearance.