510(k) K780296
K780296 is an FDA 510(k) premarket notification submitted by Convaid Product Development for the device "THERAPY SCOOTER". The FDA issued a decision of Substantially Equivalent on February 24, 1978. The device falls under product code KNL (Board, Scooter, Prone), a Class I device regulated under 21 CFR 890.5370.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 24, 1978
- Date Received
- February 21, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Board, Scooter, Prone
- Device Class
- Class I
- Regulation Number
- 890.5370
- Review Panel
- PM
- Submission Type