510(k) K243613
K243613 is an FDA 510(k) premarket notification submitted by Transtimulation Research, Inc. for the device "Patch-TEA (Model TRI-21)". The FDA issued a decision of Substantially Equivalent on April 9, 2025. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Transtimulation Research, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 2025
- Date Received
- November 22, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Nerve, Transcutaneous, Over-The-Counter
- Device Class
- Class II
- Regulation Number
- 882.5890
- Review Panel
- NE
- Submission Type
TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES