IOD · Components, Exercise
Physical Medicine · 21 CFR 890.5350 · Class 1
Overview
| Product Code | IOD |
|---|---|
| Device Name | Components, Exercise |
| Regulation | 21 CFR 890.5350 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
An exercise component is a device that is used in conjunction with other forms of exercise and that is intended for medical purposes, such as to redevelope muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include weights, dumbbells, straps, and adaptive hand mitts.
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.
Recent Cleared Devices (11 of 11)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K831544 | DELUXE TRACTION EXERCISE GLOVE BK5035 | Fred Sammons, Inc. | Jun 24, 1983 | SESE |
| K823648 | SURGICAL TUBING | Fred Sammons, Inc. | Jan 21, 1983 | SESE |
| K823822 | ANKLE WEIGHTS | Danek Medical, Inc. | Jan 14, 1983 | SESE |
| K823600 | SOLID WOOD CONE | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K813632 | COLOR CODED WEIGHT CUFFS | Fred Sammons, Inc. | Jan 19, 1982 | SESE |
| K812319 | THERAPY BENCH | Kaye Products, Inc. | Aug 31, 1981 | SESE |
| K790587 | CANVAS WEDGE | Maddak, Inc. | Apr 3, 1979 | SESE |
| K772414 | SANDBAGS, VARIOUS WEIGHTS | Fred Sammons, Inc. | Feb 1, 1978 | SESE |
| K771030 | FLEXION MITTENS | Stat Medical Corp. | Jun 27, 1977 | SESE |
| K761119 | SHEET METAL CLAMP | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
| K761118 | HAND SCREW CLAMP | Fred Sammons, Inc. | Dec 2, 1976 | SESE |
Top Applicants
- Fred Sammons, Inc. — 7 clearances
- Danek Medical, Inc. — 1 clearance
- Kaye Products, Inc. — 1 clearance
- Maddak, Inc. — 1 clearance
- Stat Medical Corp. — 1 clearance
