BXB · Exerciser, Powered
Physical Medicine · 21 CFR 890.5380 · Class 1
Overview
| Product Code | BXB |
|---|---|
| Device Name | Exerciser, 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 160)
Showing 20 most recent of 160 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K072887 | G-TRAINER MEDICAL | Alter-G, Inc. | Jan 25, 2008 | SESE |
| K003272 | FLO-BOOT | Discovery Group, LLC | Apr 4, 2001 | SESE |
| K952975 | ANKLE CALF EXERCISER PHLEBOPUMP | Prevent Products, Inc. | Sep 25, 1996 | SESE |
| K953456 | E-Z FLEX | Fluid Motion Biotechnologies, Inc. | Jan 26, 1996 | SESE |
| K955106 | BTE CPM-20 | Baltimore Therapeutic Equipment Co. | Dec 29, 1995 | SESE |
| K955105 | BTE CPM-10 | Baltimore Therapeutic Equipment Co. | Dec 29, 1995 | SESE |
| K951028 | HAMEX TWO | Northern Orthopaedic Products, Inc. | Dec 11, 1995 | SESE |
| K950755 | FLEXMATE K500 | Breg, Inc. | Oct 5, 1995 | SESE |
| K951029 | HAMEX ONE | Northern Orthopaedic Products, Inc. | Sep 15, 1995 | SESE |
| K945733 | AQUAHAB, MODEL 120-72-101 | Aquarius Electronics, Inc. | Sep 15, 1995 | SESE |
| K950682 | W2 WRIST CPM UNIT | Toronto Medical Corp. | Sep 13, 1995 | SESE |
| K952369 | KRD PL 2000 CONTROLLED PASSIVE MOTION (CPM) PORTABLE | Physicians Consulting, Inc. | Aug 7, 1995 | SESE |
| K945690 | BACKCYCLER CPM(TM) | Ergomedics, Inc. | Jun 22, 1995 | SESE |
| K946169 | ACTIC 2002 | North Atlantic Rehabilitation, Inc. | Jun 15, 1995 | SESE |
| K945824 | GALAXY MD SERIES THERAPYPOOLS | Galaxy Aquatics, Inc. | Apr 5, 1995 | SESE |
| K944819 | KRDL 2000 | Physicians Consulting, Inc. | Mar 10, 1995 | SESE |
| K945221 | SUTTER MODEL 6000 HAND CPM DEVICE | Sutter Corp. | Feb 27, 1995 | SESE |
| K945121 | A3 ANKLE CPM UNIT | Toronto Medical, Inc. | Feb 17, 1995 | SESE |
| K940455 | LATERAL FLEXION MACHINE | Rehab, Inc. | Jan 12, 1995 | SN |
| K935011 | SWIMEX MULTIDEPTH POOL (MODEL 600T) | Swimex Systems | Jan 9, 1995 | SESE |
Top Applicants
- Allied Associates, Inc. — 9 clearances
- Buckman Co., Inc. — 8 clearances
- Invacare Corp. — 8 clearances
- Toronto Medical Corp. — 7 clearances
- Sutter Corp. — 5 clearances
