KNL · Board, Scooter, Prone
Physical Medicine · 21 CFR 890.5370 · Class 1
Overview
| Product Code | KNL |
|---|---|
| Device Name | Board, Scooter, Prone |
| Regulation | 21 CFR 890.5370 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
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.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K841695 | CRAWLER | Maddak, Inc. | May 10, 1984 | SESE |
| K811489 | SCOOTER BOARD | Fred Sammons, Inc. | Jun 12, 1981 | SESE |
| K790528 | THERAPY GYROSCOPE | Maddak, Inc. | Apr 3, 1979 | SESE |
| K781198 | BOARD, SCOOTER | Fred Sammons, Inc. | Jul 31, 1978 | SESE |
| K780296 | THERAPY SCOOTER | Convaid Product Development | Feb 24, 1978 | SESE |
Top Applicants
- Fred Sammons, Inc. — 2 clearances
- Maddak, Inc. — 2 clearances
- Convaid Product Development — 1 clearance
