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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name stimulator, nerve, transcutaneous, over-the-counter
510(k) Number K241509
Device Name TENS&EMS units (SM9109A, SM9109B)
Applicant
Plexus Yoga LLC Dba Chirp
3900 N Traverse Mountain Blvd Suite 300
Lehi,  UT  84043
Applicant Contact Jianhua Xu
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number882.5890
Classification Product Code
NUH  
Subsequent Product Code
NGX  
Date Received05/28/2024
Decision Date 06/27/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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