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510(k) K160508

Electronic Pulse Stimulator by Beijing Choice Electronic Technololgy Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 21, 2016
Date Received
February 24, 2016
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 Beijing Choice Electronic Technololgy Co., Ltd.

  • K151206 — Fingertip Pulse Oximeter (August 28, 2015)
  • K142888 — Fingertip Pulse Oximeter (February 20, 2015)
  • K141024 — EXTERNAL PULSE OXIMETER (January 13, 2015)
  • K141128 — FINGERTIP PULSE OXIMETER (August 13, 2014)
  • K140682 — FINGERTIP PULSE OXIMETER (July 17, 2014)
  • K131047 — FINGERTIP PULSE OXIMETER (October 16, 2013)
  • K130947 — FINGERTIP PULSE OXIMETER (October 3, 2013)
  • K123871 — FINGERTIP PULSE OXIMETER (May 10, 2013)
  • K122046 — WRIST PULSE OXIMETER (February 4, 2013)
  • K112622 — HANDHELD ECG MONITOR (July 19, 2012)

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)