510(k) K233006
K233006 is an FDA 510(k) premarket notification submitted by Myndtec, Inc. for the device "MyndMove, MyndMove 2.0". The FDA issued a decision of Substantially Equivalent on June 25, 2024. The device falls under product code GZI (Stimulator, Neuromuscular, External Functional), a Class II device regulated under 21 CFR 882.5810. Myndtec, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 25, 2024
- Date Received
- September 22, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Neuromuscular, External Functional
- Device Class
- Class II
- Regulation Number
- 882.5810
- Review Panel
- NE
- Submission Type