meddevicedb.com FDA Device Reference

Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.)

K261131 Class II Traditional
Decision Date
2026-09-06
Sponsor / Applicant
Shenzhen Osto Medical Technology Co.,Ltd

Technical Specification

510(k) Submission ID K261131
Product Code NUH
Medical Specialty / Panel Neurology
Regulation Citation 21 CFR 882.5890
Decision Date 2026-09-06
Clearance Pathway Traditional

Official Documentation

FDA CDRH Summary / statement of record

View FDA Summary PDF

Clearance Summary

Electrical Muscle Stimulator (AST-105DJ, AST-105EJ, AST- 105BJ, AST-105GJ, AST-303J, AST-309J, AST-310J;AST-300Q, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST- 500U, AST- 500D; AST- 500E.) received FDA 510(k) clearance under submission number K261131, sponsored by Shenzhen Osto Medical Technology Co.,Ltd. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-09-06.

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.