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Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W)

K211736 Class II Traditional
Decision Date
2021-09-05
Sponsor / Applicant
Shenzhen Osto Technology Company Limited

Technical Specification

510(k) Submission ID K211736
Product Code NUH
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5890
Decision Date 2021-09-05
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) received FDA 510(k) clearance under submission number K211736, sponsored by Shenzhen Osto Technology Company Limited. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2021-09-05.

Classification & Regulation

This clearance is catalogued under FDA product code NUH and 21 CFR 882.5890, within the Neurology review panel as a Class II device.