510(k) K241509
K241509 is an FDA 510(k) premarket notification submitted by Plexus Yoga, LLC Dba Chirp for the device "TENS&EMS units (SM9109A, SM9109B)". The FDA issued a decision of Substantially Equivalent on June 27, 2024. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 27, 2024
- Date Received
- May 28, 2024
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
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