IOL · Treadmill, Powered
Physical Medicine · 21 CFR 890.5380 · Class 1
Overview
| Product Code | IOL |
|---|---|
| Device Name | Treadmill, Powered |
| Regulation | 21 CFR 890.5380 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
Identification
Powered exercise equipment consist of powered devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a powered treadmill, a powered bicycle, and powered parallel bars.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9.
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K950377 | PARKER MODEL PE | Parker Treadmill Co., Inc. | Sep 6, 1995 | SESE |
| K950376 | PARKER MODEL PM | Parker Treadmill Co., Inc. | Sep 6, 1995 | SESE |
| K925839 | TRACKMASTER | Jas Manufacturing Co., Inc. | Jun 24, 1993 | SESE |
| K930261 | RTM REHABILITATION TREADMILL, MODEL #945-200 | Biodan Medical Systems, Ltd. | May 26, 1993 | SESE |
| K904556 | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB | Boston Scientific Corp | Dec 18, 1991 | SESE |
| K913518 | TA620 TREADMILL CONTROLLER | Siemens Burdick, Inc. | Oct 24, 1991 | SESE |
| K910867 | T600 TREADMILL | Siemens Burdick, Inc. | May 31, 1991 | SESE |
| K911751 | MEDTRACK TREADMILL | Quinton, Inc. | May 29, 1991 | SESE |
| K897179 | ORBITER(TM) TREADMILL | Lee-Meredith Industries, Inc. | Feb 15, 1990 | SESE |
| K895104 | AQUATREX UNDERWATER TREADMILL SYSTEM | Edmonds Medical Systems | Dec 4, 1989 | SESE |
| K893032 | PACER R 9 TREADMILL | Pacer Industries, Inc. | Jul 27, 1989 | SESE |
| K890793 | STARTRAC | Unisen, Inc. | Mar 16, 1989 | SESE |
| K885062 | MODIFIED Q-SERIES OF TREADMILLS | Quinton, Inc. | Dec 27, 1988 | SESE |
| K864013 | MODEL Q55XT POWERED TREADMILL | Quinton, Inc. | Nov 14, 1986 | SESE |
| K863299 | MODIFIED Q50 MEDICAL TREADMILL | Quinton, Inc. | Sep 9, 1986 | SESE |
| K862741 | Q50 MEDICAL TREADMILL | Quinton, Inc. | Jul 29, 1986 | SESE |
| K861347 | R1596 POWERED EXERCISE EQUIPMENT | Tri W-G, Inc. | May 2, 1986 | SESE |
| K854147 | BATTLE CREEK BOARDWALKER ELECTRIC TREADMILL | Battle Creek Equipment Co. | Dec 27, 1985 | SESE |
| K854148 | BATTLE CREEK DIGI-TRACKER ELCTRIC TREADMILL | Battle Creek Equipment Co. | Dec 17, 1985 | SESE |
| K854283 | CAMBRIDGE MODEL XT1000 | Cambridge Medical Instruments, Inc. | Nov 13, 1985 | SESE |
Top Applicants
- Quinton, Inc. — 9 clearances
- Battle Creek Equipment Co. — 3 clearances
- Burdick Corp. — 3 clearances
- Eaton Medical Group — 3 clearances
- Erich Jaeger, Inc. — 2 clearances
