FDA Registration
Active
🇨🇳 China
BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD.
Reg #: 3023237645
·
FEI: 3023237645
·
Expires 2026
Products
6
Proprietary Names
8
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD.
- Registration Number
- 3023237645
- FEI Number
- 3023237645
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Jianghuai Supply Base, Zhongkai Group, Mengcheng County
- City
- Bozhou Anhui
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K213879
Owner / Operator
- Firm Name
- Bozhou Rongjian Medical Appliance Co., Ltd.
- Operator Number
- 10084937
- Address
- Jianghuai Supply Base, Zhongkai Group, Mengcheng County
- City
- Bozhou
- State
- Anhui
- Postal Code
- 233500
- Country
- CN
- Correspondent
- Zhifang Wu
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Cutaneous | GXY | Class 2 | Neurology | No | 2022-04-17 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | Class 2 | Neurology | No | 2023-01-29 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | Class 2 | Neurology | No | 2025-12-05 |
| Stimulator, Electro-Acupuncture | BWK | Class U | Unknown | No | 2022-04-17 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2024-12-08 |
| Needle, Acupuncture, Single Use | MQX | Class 2 | General Hospital | No | 2022-04-17 |
Proprietary Names
Self-adhesive Electrode
Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1)
Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
Needle Stimulator (Model: RJNS6-1)
Infrared Lamp
Sterile Acupuncture Needles
Dry Needles
Seven-star Needles
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device