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510(k) K240292

Transcutaneous Electrical Nerve Stimulator (9029SCM) by Hong Kong Etech Groups Limited — Product Code NUH

K240292 is an FDA 510(k) premarket notification submitted by Hong Kong Etech Groups Limited for the device "Transcutaneous Electrical Nerve Stimulator (9029SCM)". The FDA issued a decision of Substantially Equivalent on March 25, 2024. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 25, 2024
Date Received
February 1, 2024
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 for product code NUH

  • K260412 — TENS 7000 Rechargeable 4 Channel (TENS 7000H) (June 26, 2026)
  • K260425 — TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) (June 16, 2026)
  • 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)

FDA data resources