The following data is part of a premarket notification filed by Therapy Air Support Systems, Inc. with the FDA for Tassi Mk2.
| Device ID | K884835 |
| 510k Number | K884835 |
| Device Name: | TASSI MK2 |
| Classification | Bed, Air Fluidized |
| Applicant | THERAPY AIR SUPPORT SYSTEMS, INC. 13912 PONDEROSA, UNIT-H Santa Ana, CA 92705 |
| Contact | Bill Ross |
| Correspondent | Bill Ross THERAPY AIR SUPPORT SYSTEMS, INC. 13912 PONDEROSA, UNIT-H Santa Ana, CA 92705 |
| Product Code | INX |
| CFR Regulation Number | 890.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-18 |
| Decision Date | 1988-12-07 |