The following data is part of a premarket notification filed by Aquatherapy Systems, Inc. with the FDA for Thera-fit.
| Device ID | K930821 |
| 510k Number | K930821 |
| Device Name: | THERA-FIT |
| Classification | Bath, Hydro-massage |
| Applicant | AQUATHERAPY SYSTEMS, INC. 462 GERMANTOWN PIKE Lafayette Hill, PA 19444 |
| Contact | Charles Carfagno |
| Correspondent | Charles Carfagno AQUATHERAPY SYSTEMS, INC. 462 GERMANTOWN PIKE Lafayette Hill, PA 19444 |
| Product Code | ILJ |
| CFR Regulation Number | 890.5100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-02-17 |
| Decision Date | 1994-11-09 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() THERA-FIT 75453961 2234248 Dead/Cancelled |
Krumbeck, Keith 1998-03-20 |
![]() THERA-FIT 75453961 2234248 Dead/Cancelled |
Krumbeck, Cindy 1998-03-20 |
![]() THERA-FIT 74492877 not registered Dead/Abandoned |
Morrison, Clay F. 1994-02-22 |