The following data is part of a premarket notification filed by Sauna Magic, Inc. with the FDA for Saunette, Portable Steam Cabin.
| Device ID | K914234 |
| 510k Number | K914234 |
| Device Name: | SAUNETTE, PORTABLE STEAM CABIN |
| Classification | Cabinet, Moist Steam |
| Applicant | SAUNA MAGIC, INC. 5500 TOMKEN ROAD, UNIT #9 Mississauga, Ontario, CA L4w 2z4 |
| Contact | Indra Soogrim |
| Correspondent | Indra Soogrim SAUNA MAGIC, INC. 5500 TOMKEN ROAD, UNIT #9 Mississauga, Ontario, CA L4w 2z4 |
| Product Code | IMB |
| CFR Regulation Number | 890.5250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-20 |
| Decision Date | 1992-02-11 |