The following data is part of a premarket notification filed by Edmonds Medical Systems with the FDA for Aquatrex Underwater Treadmill System.
| Device ID | K895104 |
| 510k Number | K895104 |
| Device Name: | AQUATREX UNDERWATER TREADMILL SYSTEM |
| Classification | Treadmill, Powered |
| Applicant | EDMONDS MEDICAL SYSTEMS 7711 230TH S.W. Edmonds, WA 98020 |
| Contact | Roger Keller |
| Correspondent | Roger Keller EDMONDS MEDICAL SYSTEMS 7711 230TH S.W. Edmonds, WA 98020 |
| Product Code | IOL |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-08-15 |
| Decision Date | 1989-12-04 |