Shenzhen Dongdixin Technology Co., Ltd.: FDA filings under this applicant name
FDA lists 26 510(k) clearances under the applicant name “Shenzhen Dongdixin Technology Co., Ltd.” (first 2005, latest 2026), across 13 product codes in 4 review panels. Median 510(k) review time under this name: 150 days. Since 2017 the median was 136 days, against 163 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 302 |
| 2013 | 2 | 208 |
| 2014 | 3 | 203 |
| 2015 | 2 | 292 |
| 2016 | 1 | 147 |
| 2017 | 3 | 94 |
| 2018 | 2 | 220 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 129 |
| 2022 | 1 | 156 |
| 2023 | 0 | — |
| 2024 | 1 | 120 |
| 2025 | 0 | — |
| 2026 | 1 | 137 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Shenzhen Dongdixin Technology Co., Ltd. took a median 136 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 163 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 6 | 6 |
| FLL | Continuous Measurement Thermometer | 4 | 4 |
| IPF | Stimulator, Muscle, Powered | 4 | 4 |
| IMG | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | 3 | 3 |
| GXY | Electrode, Cutaneous | 1 | 1 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| ILY | Lamp, Infrared, Therapeutic Heating | 1 | 1 |
| IMI | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| IMJ | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | 1 | 1 |
| ISA | Massager, Therapeutic, Electric | 1 | 1 |
Plus 3 more product codes.
Review panels
Most recent Shenzhen Dongdixin Technology Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K260412 | TENS 7000 Rechargeable 4 Channel (TENS 7000H) | NUH | 2026-06-26 | 137 |
| K240358 | ShockPhysio Mobile (model SW3200 Basic) | ISA | 2024-06-05 | 120 |
| K213043 | Levator Elite (Model LE9011) | IPF | 2022-02-25 | 156 |
| K210364 | Migraine Tens Digital Pain Reliever | PCC | 2021-06-17 | 129 |
| K180331 | Wireless Pain Relieve Device | NUH | 2018-06-22 | 136 |
| K171430 | Incontinence Treatment Device, Model LT2061 | KPI | 2018-03-15 | 304 |
| K173462 | Wireless Pain Relieve Device Model: LT5018C | NUH | 2017-12-08 | 30 |
| K171978 | Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10 | IPF | 2017-10-02 | 94 |
| K162479 | Smart Pain Reliever, Model LT5019 | NUH | 2017-02-08 | 155 |
| K161735 | Non-contact Forehead Thermometer | FLL | 2016-11-17 | 147 |
16 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Shenzhen Dongdixin Technology Co., Ltd..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Shenzhen Dongdixin Technology Co., Ltd. (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (159 510(k)s)
- Shenzhen Kaiyan Medical Equipment Co., Ltd. (24 510(k)s)
- Shenzhen TPH Technology Co., Ltd. (24 510(k)s)
- Shenzhen Ulike Smart Electronics Co., Ltd. (23 510(k)s)
- Shenzhen AOJ Medical Technology Co., Ltd. (17 510(k)s)
- Shenzhen Beacon Display Technology Co., Ltd. (17 510(k)s)
- Shenzhen Med-Link Electronics Tech Co., Ltd. (14 510(k)s)
- Shenzhen Root Innovation Technology Co., Ltd. (13 510(k)s)
- Shenzhen Osto Technology Company Limited (12 510(k)s)
- Shenzhen RF Tech Co., Ltd. (12 510(k)s)
- Shenzhen Creative Industry Co., Ltd. (11 510(k)s)
- Shenzhen Jumper Medical Equipment Co., Ltd. (10 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Shenzhen Dongdixin Technology Co., Ltd.?
FDA lists 26 510(k) clearances under the applicant name “Shenzhen Dongdixin Technology Co., Ltd.” (first 2005, latest 2026), across 13 product codes in 4 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Shenzhen Dongdixin Technology Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Shenzhen Dongdixin Technology Co., Ltd. is 150 days. Since 2017: 136 days, versus 163 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Shenzhen Dongdixin Technology Co., Ltd.?
The most frequent FDA product codes under this applicant name are NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 6); FLL (Continuous Measurement Thermometer, 4); IPF (Stimulator, Muscle, Powered, 4).
Next steps
- See all 26 Shenzhen Dongdixin Technology Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code NUH, Shenzhen Dongdixin Technology Co., Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.