The following data is part of a premarket notification filed by American Biosystems, Inc. with the FDA for Thairapy System.
| Device ID | K936121 |
| 510k Number | K936121 |
| Device Name: | THAIRAPY SYSTEM |
| Classification | Percussor, Powered-electric |
| Applicant | AMERICAN BIOSYSTEMS, INC. SUITE 116 St. Paul, MN 55110 |
| Contact | Philip R Rose |
| Correspondent | Philip R Rose AMERICAN BIOSYSTEMS, INC. SUITE 116 St. Paul, MN 55110 |
| Product Code | BYI |
| CFR Regulation Number | 868.5665 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-23 |
| Decision Date | 1994-08-02 |