510(k) K820964
K820964 is an FDA 510(k) premarket notification submitted by Pryor Products for the device "WHEELCHAIR PAL". The FDA issued a decision of Substantially Equivalent on April 16, 1982. The device falls under product code KNO (Accessories, Wheelchair), a Class I device regulated under 21 CFR 890.3910. Pryor Products has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 16, 1982
- Date Received
- April 6, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Wheelchair
- Device Class
- Class I
- Regulation Number
- 890.3910
- Review Panel
- PM
- Submission Type