FDA Registration
Active
🇨🇳 China
Shenzhen Dongdixin Technology Co., Ltd.
Reg #: 3005170249
·
FEI: 3005170249
·
Expires 2026
Products
18
Proprietary Names
1
Establishment Types
3
Classifications
18
Registration Details
- Registration Name
- Shenzhen Dongdixin Technology Co., Ltd.
- Registration Number
- 3005170249
- FEI Number
- 3005170249
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate Xilixiaobaimang, Nanshan District,
- City
- SHENZHEN Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K142976
Owner / Operator
- Firm Name
- SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.
- Operator Number
- 9073156
- Address
- Floor 1-2, No.3 Building, Fanshen Xusheng Industrial Estate, Xilixiaobaimang Nanshan District,
- City
- SHENZHEN
- State
- Guangdong
- Postal Code
- 518108
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- CHARLES MACK
- Address
- 2091 Oak Drive
- City
- Lake Havasu City
- State
- AZ
- ZIP
- 86406
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2015-10-22 |
| Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat | IMI | Class 2 | Physical Medicine | No | 2015-10-22 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2013-09-21 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2013-09-21 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2024-06-17 |
| Stimulator, Neuromuscular, External Functional | GZI | Class 2 | Neurology | No | 2015-11-20 |
| Interferential Current Therapy | LIH | Class 2 | Neurology | No | 2015-11-20 |
| Stimulator, Muscle, Powered | IPF | Class 2 | Physical Medicine | No | 2015-11-20 |
| Device, Biofeedback | HCC | Class 2 | Neurology | No | 2015-11-20 |
| Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat | IMG | Class 2 | Physical Medicine | No | 2015-11-20 |
| Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | PCC | Class 2 | Neurology | No | 2024-05-29 |
| Stimulator, Electrical, Non-Implantable, For Incontinence | KPI | Class 2 | Gastroenterology, Urology | No | 2023-06-13 |
| Cable, Electrode | IKD | Class 2 | Physical Medicine | No | 2012-06-18 |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | Class 2 | Neurology | No | 2017-12-10 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2014-03-31 |
| Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat | IMJ | Class 2 | Physical Medicine | No | 2014-03-31 |
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2014-11-19 |
| Clinical Electronic Thermometer | SDV | Class 2 | General Hospital | No | 2025-07-03 |
Proprietary Names
TENS UNIT ETU-134
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device for Another Party (Contract Manufacturer)