# Shenzhen Kentro Medical Electronics Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 10 (2017–2024): 10 510(k) clearances
- Product codes: NUH (9), NGX (1)
- 510(k) review time since 2016: median 186 days, against 137 for FDA's reviews in the same codes and years (2 of 10 faster)
- Predicates its devices cite: 14 (3 its own); citations of its devices by later devices: 4 (3 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
- M.I.Tech Co., Ltd.: 2 (https://510kreport.com/company/mitech)
- Shenzhen Osto Technology Company Limited: 2 (https://510kreport.com/company/shenzhen-osto-technology)
- Guangzhou Xinbo Electronic Co., Ltd.: 1 (https://510kreport.com/company/guangzhou-xinbo-electronic)
- Endurance Therapeutics: 1 (https://510kreport.com/company/endurance-therapeutics)
- Tyece, Ltd.: 1 (https://510kreport.com/company/tyece)
- Easymed Instruments Co., Ltd.: 1 (https://510kreport.com/company/easymed-instruments)
- Actegy, Ltd.: 1 (https://510kreport.com/company/actegy)
- Well Brain International, Ltd.: 1 (https://510kreport.com/company/well-brain-international)

## Firms that cite its devices most
- Hong Kong Etech Groups Limited: 1 (https://510kreport.com/company/hong-kong-etech-groups)

## Its most-cited devices
- K191982: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (2020), cited by 2
- K183288: Transcutaneous Electrical Nerve Stimulator (2019), cited by 1
- K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (2022), cited by 1

## Recent decisions
- K242332: Transcutaneous Electronic Nerve Stimulator  (KTR-2301, KTR-2302, KTR-2341, KTR-2342, KTR-2401, KTR-2402, KTR-2411, KTR-2412, KTR-2491, KTR-2492, KTR-2493, KTR-2494) (Nov 5, 2024)
- K232517: Transcutaneous Electrical Nerve Stimulator For Pain Relief (Model: KTR-2302, KTR-2401, KTR-2402, KTR-2411, KTR-2412) (Dec 8, 2023)
- K222870: Transcutaneous Electrical Nerve Stimulator, Model: KTR-4031, KTR-4032, KTR-4012, KTR-4015, KTR-4029, KTR-4027, KTR-4026, KTR-4021, KTR-4034, KTR-4036, KTR-4037, KTR-4039 (May 10, 2023)
- K220998: Transcutaneous Electrical Nerve Stimulator, Model: KTR-405 (Aug 24, 2022)
- K200177: Low-frequency Multi-function physiotherapy instrument (Mar 25, 2021)
- K200237: Transcutaneous Electronic Nerve Stimulator (Oct 19, 2020)
- K191982: Low-Frequency Multi-function Physiotherapy Instrument (Model: KTR-2230, KTR-2220, KTR-2210, KTR-2231, KTR-2221, KTR-2211, KTR-2232, KTR-2222, KTR-2212) (Sep 25, 2020)
- K183288: Transcutaneous Electrical Nerve Stimulator (Jul 30, 2019)

Source page: https://510kreport.com/company/shenzhen-kentro-medical-electronics