MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB
Device Facts
| Record ID | K904556 |
|---|---|
| Device Name | MANSFIELD CARDIAC ASSIST MODEL 940(TM) IAB |
| Applicant | Boston Scientific Corp |
| Product Code | IOL · Physical Medicine |
| Decision Date | Dec 18, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.5380 |
| Device Class | Class 1 |
Regulatory Classification
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.
