DYNASTY U1-31 (GELL/CELL)
Device Facts
| Record ID | K942309 |
|---|---|
| Device Name | DYNASTY U1-31 (GELL/CELL) |
| Applicant | Foley & Lardner |
| Product Code | KNN · Physical Medicine |
| Decision Date | Nov 7, 1994 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 890.3920 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A wheelchair component is a device intended for medical purposes that is generally sold as an integral part of a wheelchair, but may also be sold separately as a replacement part. Examples of wheelchair components are the following: Armrest, narrowing attachment, belt, extension brake, curb climber, cushion, antitip device, footrest, handrim, hill holder, leg rest, heel loops, and toe loops.
