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510(k) K190783

Health Expert Electronic Stimulator (model: AST-300L) by Shenzhen Osto Technology Company Limited — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 2020
Date Received
March 27, 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)
  • K190673 — Health Expert Electronic Stimulator (December 12, 2019)
  • K133929 — HEALTH EXPERT ELCTRONIC STIMULATOR (November 12, 2014)

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  • K250784 — Transcutaneous Electrical Nerve Stimulator ( K6133/ K6134/ K6135/ K6136/ K6137/ (August 21, 2025)
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