510(k) K183692
K183692 is an FDA 510(k) premarket notification submitted by Vision Quest Industries Inc./Dba VQ Orthocare for the device "Avid IF2". The FDA issued a decision of Substantially Equivalent on June 12, 2019. The device falls under product code LIH (Interferential Current Therapy), a Class II device regulated under 21 CFR 882.5890. 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
- June 12, 2019
- Date Received
- December 31, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interferential Current Therapy
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type