510(k) K770086
- Device
- SANAR
- Applicant
- Health Improvement Assoc.
- 510(k) number
- K770086
- Product code
- IMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-04-18
- Date received
- 1977-01-14
- Regulation
- 890.5250
- Classification name
- Cabinet, Moist Steam
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3013689783
- 3021656665
- 3010427504
- 3013395414
- 3013601329
- 3015063984
- 3013627744
- 3030650016
- 3004126239
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code IMB#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K003916 | DERMALIFE HYDROFUSION SKIN & BODY CARE SYSTEM | Scandia Manufacturing , Ltd. | 2002-04-15 |
| K955808 | DYNA T-2000 PHYSICAL THERAPY SYSTEM | Thermia, Inc. | 1997-11-03 |
| K914234 | SAUNETTE, PORTABLE STEAM CABIN | Sauna Magic, Inc. | 1992-02-11 |
| K810320 | HEATPAC | Shinsei Corp. | 1981-03-04 |