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510(k) K251187

3 in 1 TENS UNIT (TC1241, TC2241, TS1241) by Changsha Anxiang Medical Technology Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 28, 2025
Date Received
April 17, 2025
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

Other clearances by Changsha Anxiang Medical Technology Co., Ltd.

  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K251706 — TENS and EMS Unit (July 30, 2025)
  • K250759 — 3 in 1 TENS UNIT (June 13, 2025)
  • K243763 — Wireless TENS & EMS Unit (March 12, 2025)
  • K243511 — OTC TENS & EMS Unit (February 10, 2025)
  • K242787 — Tens & Ems Device (TU1080) (December 18, 2024)
  • K242567 — Muscle and Nerve Stimulator TENS & EMS (TP2208), Muscle and Nerve Stimulator TEN (November 4, 2024)

Other clearances for product code NUH

  • K253896 — TENS/EMS device (GUSE01) (March 4, 2026)
  • K253305 — TENS AND EMS (TENS and Muscle Stimulator) (JT1065, JT1080, JT2080, JT9034) (December 31, 2025)
  • K251958 — VEINOPLUS Back (December 23, 2025)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K252688 — Transcutaneous Electrical Nerve Stimulator (RJTENS-2) (November 24, 2025)
  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K243131 — Triathlon Pro (November 7, 2025)
  • K251429 — OTC 4-Channel Rechargeable TENS Unit (August 28, 2025)
  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
  • K243856 — TENS AND EMS (TENS and Muscle Stimulator) ( Model AS8012C,AS8016,AS8019,AS9020E, (May 29, 2025)