# Shenzhen Osto Technology Company Limited

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 12 (2014–2022): 12 510(k) clearances
- Names in FDA's records: Shenzhen Osto Technology Company Limited (7); Shenzhen Osto Technology Co., Ltd. (5)
- Product codes: NUH (10), NGX (1), OLP (1)
- 510(k) review time since 2016: median 288 days, against 198 for FDA's reviews in the same codes and years (4 of 11 faster)
- Predicates its devices cite: 17 (11 its own); citations of its devices by later devices: 26 (11 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Jkh Health Co., Ltd.: 1 (https://510kreport.com/company/jkh-health)
- Johari Digital Healthcare, Ltd.: 1 (https://510kreport.com/company/johari-digital-healthcare)
- Omron Healthcare, Inc.: 1 (https://510kreport.com/company/omron-healthcare)
- Hong Qiangxing (Shenzhen) Electronics Limited: 1 (https://510kreport.com/company/hong-qiangxing-shenzhen-electronics)
- Prospera Corporation: 1 (https://510kreport.com/company/prospera)
- Jkh USA, LLC: 1 (https://510kreport.com/company/jkh-usa)

## Firms that cite its devices most
- Shenzhen Leqing Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-leqing-medical-instrument)
- Shenzhen Kentro Medical Electronics Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-kentro-medical-electronics)
- Shenzhen Future Electronic Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-future-electronic)
- Guandong Skg Intelligent Technology Co., Ltd.: 1 (https://510kreport.com/company/guandong-skg-intelligent-technology)
- Guangzhou Xinbo Electronic Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-xinbo-electronic)
- Tohkai Precision Electrical Manufactory (Shenzhen) Limited: 1 (https://510kreport.com/company/tohkai-precision-electrical-manufactory-shenzhen)
- Guangzhou Huakai Electronic Technology Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-huakai-electronic-technology)
- Shenzhen Leading Perfection Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-leading-perfection-technology)

## Its most-cited devices
- K133929: Health Expert Elctronic Stimulator (2014), cited by 15
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (2020), cited by 5
- K172897: Neck Care Therapy, Model: SYK 509B (2018), cited by 3
- K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (2021), cited by 1
- K210756: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (2021), cited by 1
- K190673: Health Expert Electronic Stimulator (2019), cited by 1

## Recent decisions
- K213056: LED Facial Mask (Jul 7, 2022)
- K211942: Heating Lumbar Therapy Cushion (Model: AST-622, AST-622B, AST-623, AST-623B) (Dec 13, 2021)
- K212989: Low-frequency Stimulator (Model: AST-645, AST-646) (Nov 22, 2021)
- K211736: Electronic Muscle Stimulator (Model: AST-300A, AST-300N, AST-300S, AST-300T, AST-300V, AST-300W) (Sep 5, 2021)
- K210756: Neck Care Therapy, Model: AST-905A, AST-905D, AST-905H (Jun 11, 2021)
- K190783: Health Expert Electronic Stimulator (model: AST-300L) (Mar 14, 2020)
- K190673: Health Expert Electronic Stimulator (Dec 12, 2019)
- K182136: Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303) (Oct 10, 2019)

Source page: https://510kreport.com/company/shenzhen-osto-technology