Data / Medical devices / China / Shenzhen Dongjilian Medical Tech Co., Ltd
Shenzhen Dongjilian Medical Tech Co., Ltd: FDA-registered device maker in Shenzhen Guangdong, China, 5 510(k) clearances
Shenzhen Dongjilian Medical Tech Co., Ltd is registered with the FDA (registration 3010894709) in Shenzhen Guangdong, China. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated December 16, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010894709
- Address
- B1/1-5F,Tonglu Industrial Area,70# Tongxin Road,Tongxin Community,Longgang District, Shenzhen Guangdong, China, 518114
- Owner or operator
- Shenzhen Dongjilian Medical Tech Co., Ltd (10046564)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- April 7, 2014
- Registered through
- 2026
- Brand names listed
- Air Compression Calf Massager, Air Compression Leg Massager, Air Compression Leg Massager with Heat, Air Compression Leg Massager with Heat; FT-017A; FT-081A, Air Compression Recovery System CM-069A, Air Compression Recovery System QN-113A; QN-132A; CM-131A; FT-129A; FT-130A, Air Compression Therapy Device, Back Massager and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cushion, Flotation | KIC | 1 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Manufacturer | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| December 16, 2023 | K233536 | Air Compression Recovery System | IRP | Substantially Equivalent | Shenzhen Dongjilian Medical Tech Co., Ltd. | accessdata.fda.gov |
| September 30, 2022 | K222206 | Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) | IRP | Substantially Equivalent | Shenzhen Dongjilian Medical Tech Co., Ltd. | accessdata.fda.gov |
| November 19, 2020 | K201694 | Air Compression Therapy Device | IRP | Substantially Equivalent | Shenzhen Dongjilian Electronics Co., Ltd. | accessdata.fda.gov |
| June 29, 2020 | K200354 | Electronic stimulator | NUH | Substantially Equivalent | Shenzhen Dongjilian Electronics Co., Ltd. | accessdata.fda.gov |
| June 8, 2020 | K193354 | Air Compression Therapy Device | IRP | Substantially Equivalent | Shenzhen Dongjilian Electronics Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Massager, Powered Inflatable Tube
- All makers of Cushion, Flotation
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
Updated December 16, 2023. 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.