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510(k) K241509

TENS&EMS units (SM9109A, SM9109B) by Plexus Yoga, LLC Dba Chirp — Product Code NUH

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

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