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510(k) K190673

Health Expert Electronic Stimulator by Shenzhen Osto Technology Company Limited — Product Code NUH

K190673 is an FDA 510(k) premarket notification submitted by Shenzhen Osto Technology Company Limited for the device "Health Expert Electronic Stimulator". The FDA issued a decision of Substantially Equivalent on December 12, 2019. The device falls under product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter), a Class II device regulated under 21 CFR 882.5890. Shenzhen Osto Technology Company Limited has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 12, 2019
Date Received
March 15, 2019
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 Shenzhen Osto Technology Company Limited

  • K213056 — LED Facial Mask (July 7, 2022)
  • K211942 — Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (December 13, 2021)
  • K211736 — Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST (September 5, 2021)
  • K210756 — Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (June 11, 2021)
  • K190783 — Health Expert Electronic Stimulator (model: AST-300L) (March 14, 2020)
  • K133929 — HEALTH EXPERT ELCTRONIC STIMULATOR (November 12, 2014)

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)
  • 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)

FDA data resources