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510(k) K230829

TENS7000 Rechargeable (Model:TENS7000 Rechargeable) by Chongqing Rob Linka Science and Technology Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 26, 2023
Date Received
March 27, 2023
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 Chongqing Rob Linka Science and Technology Co., Ltd.

  • K233067 — Wireless TENS & EMS (Model SM9110,SM9113,SM9116) (July 19, 2024)
  • K233070 — Smart Muscle Training Wearables (Model:SM9027,SM9027,SM9566,SM9065N) (March 13, 2024)
  • K233092 — Pain Therapy Device (SM9075, SM9910, SM9067, SM9587W) (February 12, 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)
  • K251187 — 3 in 1 TENS UNIT (TC1241, TC2241, TS1241) (July 28, 2025)