510(k) K182333
K182333 is an FDA 510(k) premarket notification submitted by Reflexion Health, Inc. for the device "Vera". The FDA issued a decision of Substantially Equivalent on April 9, 2019. The device falls under product code LXJ (Interactive Rehabilitation Exercise Devices), a Class II device regulated under 21 CFR 890.5360. Reflexion Health, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2019
- Date Received
- August 28, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Interactive Rehabilitation Exercise Devices
- Device Class
- Class II
- Regulation Number
- 890.5360
- Review Panel
- PM
- Submission Type