STANDEX
Device Facts
| Record ID | K885343 |
|---|---|
| Device Name | STANDEX |
| Applicant | Alt, Inc. |
| Product Code | ION · Physical Medicine |
| Decision Date | May 1, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5370 |
| Device Class | Class 1 |
Regulatory Classification
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.
