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510(k) K201335

Li-Battery powered OTC TENS/EMS Combination Stimulator by Everyway Medical Instruments Co.,Ltd — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 2020
Date Received
May 20, 2020
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 Everyway Medical Instruments Co.,Ltd

  • K251856 — Li-Battery Powered OTC TENS/EMS Combination Stimulator, Model Z4 (November 21, 2025)
  • K222488 — Everyway Analog OTC TENS (November 15, 2022)
  • K213116 — Everyway Incontinence Stimulation System (December 3, 2021)
  • K202849 — Everyway Analog OTC TENS, model N103A/N302 (December 22, 2020)
  • K202470 — Li-Battery powered OTC TENS/EMS, model EM-6000, EM-6100, EM-6200 & EM-6300 (November 25, 2020)
  • K202317 — Li-Battery powered OTC TENS/EMS, model EV-804, model EV-805, & model EV-806 (November 13, 2020)
  • K192589 — Everyway OTC TENS/EMS Combination (December 19, 2019)
  • K182753 — A6 OTC Pain Relief TENS (October 26, 2018)
  • K182767 — V2 OTC Pain Relief TENS (October 26, 2018)
  • K181707 — Everyway Wireless TENS & EMS Unit (September 26, 2018)

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)
  • K253740 — TENS&EMS (HZ9151B, HZ9151C, HZ9151D) (December 23, 2025)
  • K251958 — VEINOPLUS Back (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)