510(k) K191376
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2019
- Date Received
- May 23, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Standup
- Device Class
- Class II
- Regulation Number
- 890.3900
- Review Panel
- PM
- Submission Type