21 CFR 890.5370 — Bars, Parallel, Exercise
Physical Medicine (PM) · Part 890 Subpart F—Physical Medicine Therapeutic Devices · § 890.5370
Identification
Nonmeasuring exercise equipment consist of 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 prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.
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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| IOE | Bars, Parallel, Exercise | 1 | 2 | |
| IOG | Treadmill, Mechanical | 1 | 3 | |
| ION | Exerciser, Non-Measuring | 1 | 43 | |
| KNL | Board, Scooter, Prone | 1 | 5 | |
| PKS | Exerciser, Non-Measuring For Stroke Rehabilitation | 1 | 0 |
