Shenzhen Osto Technology Co., Ltd. - FDA 510(k) Cleared Devices
Recent clearances: Low-frequency Stimulator (Model: AST-645, AST-646), Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303), Neck Care Therapy, Model: SYK 509B
5
Total
5
Cleared
0
Denied
FDA 510(k) Regulatory Record - Shenzhen Osto Technology Co., Ltd. Neurology ✕
5 devices
Cleared
Nov 22, 2021
Low-frequency Stimulator (Model: AST-645, AST-646)
Neurology
63d
Cleared
Oct 10, 2019
Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)
Neurology
430d
Cleared
Dec 07, 2018
Neck Care Therapy, Model: SYK 509B
Neurology
441d
Cleared
Nov 26, 2018
Low-frequency Multi-function physiotherapy instrument
Neurology
433d
Cleared
Sep 06, 2018
Dual output digital therapy massager
Neurology
352d