510(k) K914234
- Device
- SAUNETTE, PORTABLE STEAM CABIN
- Applicant
- SAUNA MAGIC, INC.
- 510(k) number
- K914234
- Product code
- IMB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-02-11
- Date received
- 1991-09-20
- Regulation
- 890.5250
- Classification name
- Cabinet, Moist Steam
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- INDRA SOOGRIM
- Address
- 5500 Tomken Rd., Unit #9 Mississauga, Ontario CA L4W 2Z4 L4W 2Z4
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 |
| K810320 | HEATPAC | Shinsei Corp. | 1981-03-04 |
| K770086 | SANAR | Health Improvement Assoc. | 1977-04-18 |
Legacy Summary#
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FDA Review#
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