Data / Medical devices / China / Shenzhen OSTO Medical Technology Company Limited
Shenzhen OSTO Medical Technology Company Limited: FDA-registered device maker in Shenzhen Guangdong, China, 13 510(k) clearances
Shenzhen OSTO Medical Technology Company Limited is registered with the FDA (registration 3011564440) in Shenzhen Guangdong, China. It lists 11 device types. The FDA files 13 510(k) clearances under its listings, the newest dated September 6, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3011564440
- Address
- 2104, Unit4, Building2, Zhongxin Longsheng Square, NO. 219 Shenshan Road Longgang Street, Longgang District, Shenzhen Guangdong, China, 518116
- Owner or operator
- Shenzhen OSTO Medical Technology Company Limited (10048304)
- Roles
- Complaint file establishment, Exporter to the US, Foreign private label distributor, Manufacturer, Repackager or relabeler
- First device listed
- December 28, 2014
- Registered through
- 2026
- Brand names listed
- AST- 500U, AST- 500D; AST- 500E, AST-2011A, AST-2011B, AST-802B, AST-213, AST-214, AST-E10, AST-300Q-A, AST-500B; AST-500G, AST-500F; AST-500N; AST- 500C, AST- 500K, AST-500A; AST-300E, AST-500M, AST-603, AST-2012A, AST-2012B, AST-905B, Advanced Foot Energizer-Health Expert Electronic Stimulator (Model: AST-300C, AST-300D), Air Pressure Foot MassagerAST-X10, AST-X10B, AST- X11, AST-X11B,AST-X12,AST-X20; Eye massager Model AST-211, AST-212 and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 6, 2026 | K261131 | 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.) | NUH | Substantially Equivalent | Shenzhen Osto Medical Technology Co.,Ltd | accessdata.fda.gov |
| July 7, 2022 | K213056 | LED Facial Mask | OLP | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| December 13, 2021 | K211942 | Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) | NGX | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| November 22, 2021 | K212989 | Low-frequency Stimulator (Model: AST-645, AST-646) | NUH | Substantially Equivalent | Shenzhen Osto Technology Co., Ltd. | accessdata.fda.gov |
| September 5, 2021 | K211736 | Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| June 11, 2021 | K210756 | Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| March 14, 2020 | K190783 | Health Expert Electronic Stimulator (model: AST-300L) | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| December 12, 2019 | K190673 | Health Expert Electronic Stimulator | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
| October 10, 2019 | K182136 | Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) | NUH | Substantially Equivalent | Shenzhen Osto Technology Co., Ltd. | accessdata.fda.gov |
| December 7, 2018 | K172897 | Neck Care Therapy, Model: SYK 509B | NUH | Substantially Equivalent | Shenzhen Osto Technology Co., Ltd. | accessdata.fda.gov |
| November 26, 2018 | K172837 | Low-frequency Multi-function physiotherapy instrument | NUH | Substantially Equivalent | Shenzhen Osto Technology Co., Ltd. | accessdata.fda.gov |
| September 6, 2018 | K172834 | Dual output digital therapy massager | NUH | Substantially Equivalent | Shenzhen Osto Technology Co., Ltd. | accessdata.fda.gov |
| November 12, 2014 | K133929 | HEALTH EXPERT ELCTRONIC STIMULATOR | NUH | Substantially Equivalent | Shenzhen Osto Technology Company Limited | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
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- All makers of Pad, Heating, Powered
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated September 6, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.