Aquatrex Underwater Treadmill System
FDA 510(k) K895104 · Edmonds Medical Systems
510(k) numberK895104
Submission
- Device name
- Aquatrex Underwater Treadmill System
- Applicant
- Edmonds Medical Systems
Edmonds, WA, US - Received
- August 15, 1989
- Decision date
- December 4, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOL – Treadmill, Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5380
- Specialty
- Physical Medicine
Other 510(k)s with product code IOL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950377 | Parker Model PeIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K950376 | Parker Model PMIOL · Traditional | Parker Treadmill Co., Inc. | 09/06/1995SE |
| K925839 | TrackmasterIOL · Traditional | Jas Manufacturing Co., Inc. | 06/24/1993SE |
| K930261 | RTM Rehabilitation Treadmill, Model #945-200IOL · Traditional | Biodan Medical Systems, Ltd. | 05/26/1993SE |
| K904556 | Mansfield Cardiac Assist Model 940(TM) IabIOL · Traditional | Boston Scientific Corp | 12/18/1991SE |
| K913518 | TA620 Treadmill ControllerIOL · Traditional | Siemens Burdick, Inc. | 10/24/1991SE |
| K910867 | T600 TreadmillIOL · Traditional | Siemens Burdick, Inc. | 05/31/1991SE |
| K911751 | Medtrack TreadmillIOL · Traditional | Quinton, Inc. | 05/29/1991SE |
| K897179 | Orbiter(Tm) TreadmillIOL · Traditional | Lee-Meredith Industries, Inc. | 02/15/1990SE |
| K893032 | Pacer R 9 TreadmillIOL · Traditional | Pacer Industries, Inc. | 07/27/1989SE |
Questions and answers
When was Aquatrex Underwater Treadmill System cleared by the FDA?
Aquatrex Underwater Treadmill System (K895104) received a 510(k) decision of Substantially Equivalent on December 4, 1989, 111 days after the submission was received.
What is the product code of K895104?
The FDA product code is IOL – Treadmill, Powered, a Class I (low risk) device regulated under 21 CFR 890.5380.