PELTIERTHERAPY(C) HEAT/COLD TREATMENT
FDA 510(k) clearance K871112 · decided 1987-05-06
Clearance details
- K-number
- K871112
- Device name
- PELTIERTHERAPY(C) HEAT/COLD TREATMENT
- Applicant
- Henley Intl.
- Decision
- Substantially Equivalent
- Date received
- 1987-03-19
- Decision date
- 1987-05-06
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- IMF
- Device class
- 1
- Regulation number
- 890.5940
- 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 |
|---|---|---|
| CRYOTRON-UL30 (K900419) | Henley Intl. | 1990-02-27 |
Recalls involving this device
No recalls on record reference this clearance.