510(k) K230533
K230533 is an FDA 510(k) premarket notification submitted by Cymedica Orthopedics, Inc. for the device "Motive Electrode". The FDA issued a decision of Substantially Equivalent on Mar 22, 2023. The device falls under product code GXY (Electrode, Cutaneous), a Class II device regulated under 21 CFR 882.1320. Cymedica Orthopedics, Inc. has 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 22, 2023
- Date Received
- Feb 27, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Electrode, Cutaneous
- Device Class
- Class II
- Regulation Number
- 882.1320
- Review Panel
- NE
- Submission Type
- 510(k)