510(k) K834498
K834498 is an FDA 510(k) premarket notification submitted by Winchester Industries, Inc. for the device "TRAIL CHAIR". The FDA issued a decision of Substantially Equivalent on January 30, 1984. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 30, 1984
- Date Received
- December 20, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Special Grade
- Device Class
- Class II
- Regulation Number
- 890.3880
- Review Panel
- PM
- Submission Type