Shenzhen Dongjilian Medical Tech Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 5 device types, 2 clearances.
Shenzhen Dongjilian Medical Tech Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cushion, Flotation, Massager, Therapeutic, Electric and 3 other device types. Its earliest product listing with the FDA dates from 2014.
Registration
| Registered name | Shenzhen Dongjilian Medical Tech Co., Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3010894709 |
| FEI number | 3010894709 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳市东吉联医疗科技股份有限公司 |
|---|---|
| Unified social credit code | 91440300754266120P |
| Source | provincial manufacturer licence lists |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | B1/1-5F,Tonglu Industrial Area,70# Tongxin Road,Tongxin Community,Longgang District |
| Postal code | 518114 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cushion, Flotation | Class 1 | Inflatable AIR Seat Cushion | 2020 | 52 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Red Light Therapy Waist Belt | 2022 | 235 |
| Massager, Powered Inflatable Tube | Class 2 | Air Compression Leg Massager, Rechargeable Leg Massager for Circulation, Cordless Leg Massager, CM-120A; CM-117A, Air Compression Leg Massager with Heat; FT-017A; FT-081A, Air Compression Therapy Device and 6 more | 2020 | 37 |
| Massager, Therapeutic, Electric | Class 1 | Air Compression Therapy Device, Neck Massager, Percussion Muscle Massager, Back Massager, Electric Foot Massager, Electric Handheld Massager and 8 more | 2014 | 437 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | ELectronic Stimulator, Foot Circulation Machine | 2020 | 57 |
Clearances
2 clearances name Shenzhen Dongjilian Medical Tech Co., Ltd. as applicant. 3 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K233536 | 2023-12-16 | IRP | Traditional | This company |
| K222206 | 2022-09-30 | IRP | Traditional | This company |
| K201694 | 2020-11-19 | IRP | Traditional | Shenzhen Dongjilian Electronics Co., Ltd. |
| K200354 | 2020-06-29 | NUH | Traditional | Shenzhen Dongjilian Electronics Co., Ltd. |
| K193354 | 2020-06-08 | IRP | Traditional | Shenzhen Dongjilian Electronics Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Employees | 600+ |
| Main products | Compression recovery boots, Calf massager, Leg massager, Hand massager, Foot massager |
| Certifications | ISO 9001, ISO 13485, CE, UL, RoHS, FCC, FDA |
| Export markets | 40+ countries |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.