The following data is part of a premarket notification filed by Aquaciser, Inc. with the FDA for Aquaciser In-pool Treadmill.
Device ID | K925807 |
510k Number | K925807 |
Device Name: | AQUACISER IN-POOL TREADMILL |
Classification | Exerciser, Powered |
Applicant | AQUACISER, INC. 201 GORE CREEK RD. Vail, CO 81657 |
Contact | Thomas H Hopkins |
Correspondent | Thomas H Hopkins AQUACISER, INC. 201 GORE CREEK RD. Vail, CO 81657 |
Product Code | BXB |
CFR Regulation Number | 890.5380 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-16 |
Decision Date | 1993-03-24 |