CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
FDA 510(k) clearance K011243 · decided 2001-07-06
Clearance details
- K-number
- K011243
- Device name
- CHATTANOOGA DRY HEAT WHIRLPOOL, MODEL 2000
- Applicant
- Chattanooga Group, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-04-23
- Decision date
- 2001-07-06
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- LSB
- Device class
- 2
- Regulation number
- 890.5100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Hixson, TN, 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 |
| MODEL T11 FLUIDOTHERAPY UNIT (K896817) | Henley Intl. | 1991-01-18 |
| MODEL K210 AND K211 FLUIDOTHERAPY UNITS (K871802) | Henley Intl. | 1987-09-04 |
Recalls involving this device
No recalls on record reference this clearance.