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510(k) K220150

TENS & PMS (Model: SM9126) by Hong Qiangxing (Shenzhen) Electronics Limited — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 17, 2022
Date Received
January 19, 2022
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

Other clearances by Hong Qiangxing (Shenzhen) Electronics Limited

  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K220283 — TENS & PMS (Model:SM9009, SM9021, SM9128H, SM9015, SM9055, SM9033) (May 2, 2022)
  • K220152 — TENS & PMS (Model:SM9089, SM9587, SM9592, SM9555) (April 19, 2022)
  • K201354 — TENS & PMS (December 11, 2020)
  • K190009 — Sunmas TENS & PMS (Model SM9187, SM9180L, SM9180S) (December 2, 2019)
  • K183154 — SM Electrodes (March 26, 2019)
  • K133108 — FIT BELT (August 5, 2014)
  • K121719 — SM TENS & PMS (May 10, 2013)

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)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)