# Shenzhen Dongdixin Technology Co., Ltd.

- Location (FDA's records): Shenzhen, CN
- FDA decisions: 27 (2005–2026): 27 510(k) clearances
- Product codes: NUH (6), IPF (4), FLL (4), IMG (3), IMJ (1), PCC (1), GXY (1), NGX (1), IMI (1), GZJ (1), ISA (1), ILY (1)
- 510(k) review time since 2016: median 142 days, against 146 for FDA's reviews in the same codes and years (3 of 10 faster)
- Predicates its devices cite: 18 (4 its own); citations of its devices by later devices: 20 (4 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mettler Electronics Corp.: 3 (https://510kreport.com/company/mettler-electronics)
- Medihightec Medical Co., Ltd.: 1 (https://510kreport.com/company/medihightec-medical)
- Cefaly Technology: 1 (https://510kreport.com/company/cefaly-technology)
- Philips Consumer Lifestyle B.V.: 1 (https://510kreport.com/company/philips-consumer-lifestyle)
- Chattem, Inc.: 1 (https://510kreport.com/company/chattem)
- Chattanooga Group, Inc.: 1 (https://510kreport.com/company/chattanooga-group)
- Gemore Technology Co, Ltd.: 1 (https://510kreport.com/company/gemore-technology)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)

## Firms that cite its devices most
- Shenzhen Roundwhale Technology Co., Ltd.: 2 (https://510kreport.com/company/shenzhen-roundwhale-technology)
- Philips Consumer Lifestyle B.V.: 1 (https://510kreport.com/company/philips-consumer-lifestyle)
- Pfizer, Inc.: 1 (https://510kreport.com/company/pfizer)
- Koalaty Products, Inc.: 1 (https://510kreport.com/company/koalaty-products)
- Tyece, Ltd.: 1 (https://510kreport.com/company/tyece)
- Pourang Bral, Dds, LLC: 1 (https://510kreport.com/company/pourang-bral-dds)
- Famidoc Technology Co., Ltd.: 1 (https://510kreport.com/company/famidoc-technology)
- Pain Management Technologies: 1 (https://510kreport.com/company/pain-management-technologies)

## Its most-cited devices
- K130802: Otc Electrical Stimulator (MT9001), Otc Tens Device (LT3060) (2013), cited by 7
- K093138: MT9000 Series Electro-Stimulator, Models MT9000, MT9002, MT9001, MT9004 and MT9003 (2010), cited by 3
- K173462: Wireless Pain Relieve Device Model: LT5018C (2017), cited by 2
- K171978: Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 (2017), cited by 2
- K100117: LT3000 Combo Stimulator, LT3001 Tens Stimulatory, LT3002 Ems Stimulator (2010), cited by 1
- K141076: Garment Electrodes (2014), cited by 1

## Recent decisions
- K252288: TECAR Therapy Device (TC2000, TC2001) (Oct 13, 2026)
- K260412: TENS 7000 Rechargeable 4 Channel (TENS 7000H) (Jun 26, 2026)
- K240358: ShockPhysio Mobile (model SW3200 Basic) (Jun 5, 2024)
- K213043: Levator Elite (Model LE9011) (Feb 25, 2022)
- K210364: Migraine Tens Digital  Pain  Reliever (Jun 17, 2021)
- K180331: Wireless Pain Relieve Device (Jun 22, 2018)
- K171430: Incontinence Treatment Device, Model LT2061 (Mar 15, 2018)
- K173462: Wireless Pain Relieve Device Model: LT5018C (Dec 8, 2017)

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