SAUNETTE, PORTABLE STEAM CABIN
FDA 510(k) clearance K914234 · decided 1992-02-11
Clearance details
- K-number
- K914234
- Device name
- SAUNETTE, PORTABLE STEAM CABIN
- Applicant
- Sauna Magic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1991-09-20
- Decision date
- 1992-02-11
- Days to decision
- 144 days
- Clearance type
- Traditional
- Product code
- IMB
- Device class
- 2
- Regulation number
- 890.5250
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mississauga, Ontario, CA
- 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 |
|---|---|---|
| DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM (K003916) | Scandia Manufacturing , Ltd. | 2002-04-15 |
| DYNA T-2000 PHYSICAL THERAPY SYSTEM (K955808) | Thermia, Inc. | 1997-11-03 |
| HEATPAC (K810320) | Shinsei Corp. | 1981-03-04 |
| SANAR (K770086) | Health Improvement Assoc. | 1977-04-18 |
Recalls involving this device
No recalls on record reference this clearance.