IMB — Cabinet, Moist Steam Class II
FDA product code IMB covers "Cabinet, Moist Steam", a Class II medical device regulated under 21 CFR 890.5250. Submissions are reviewed by the Physical Medicine panel. At least 5 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IMB
- Device Class
- Class II
- Regulation Number
- 890.5250
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K003916 | scandia manufacturing | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | April 15, 2002 |
| K955808 | thermia | DYNA T-2000 PHYSICAL THERAPY SYSTEM | November 3, 1997 |
| K914234 | sauna magic | SAUNETTE, PORTABLE STEAM CABIN | February 11, 1992 |
| K810320 | shinsei | HEATPAC | March 4, 1981 |
| K770086 | health improvement assoc | SANAR | April 18, 1977 |