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510(k) K252236

CP Relief Wand Rx - TENS/NMES by N & C Holdings, LLC — Product Code GZJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 15, 2025
Date Received
July 17, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, For Pain Relief
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

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  • K212618 — iRelieve Microcurrent Pain Relief System (September 14, 2022)
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  • K220503 — TENS device-EmeTerm 2, Model: YF-ZTY-E2 (April 23, 2022)
  • K202893 — Transcutaneous Electrical Nerve Stimulator (June 18, 2021)