510(k) K202490
K202490 is an FDA 510(k) premarket notification submitted by Vision Quest Industries Inc./Dba VQ Orthocare for the device "Avid CT2". The FDA issued a decision of Substantially Equivalent on November 16, 2020. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Vision Quest Industries Inc./Dba VQ Orthocare has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 16, 2020
- Date Received
- August 31, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type