IRR · Bars, Parallel, Powered
Physical Medicine · 21 CFR 890.5380 · Class 1
Overview
| Product Code | IRR |
|---|---|
| Device Name | Bars, Parallel, 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 (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K932240 | MODEL 5200-10,5200-12 HI-LOW ELEC. PARRALLEL BARS | Bailey Mfg. Co. | Apr 1, 1994 | SESE |
Top Applicants
- Bailey Mfg. Co. — 1 clearance
