Bozhou Rongjian Medical Appliance Co., Ltd.
Manufacturer and brand owner in Bozhou, Anhui, China. 6 device types, 4 products catalogued, 4 clearances.
Bozhou Rongjian Medical Appliance Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Electrode, Cutaneous, Needle, Acupuncture, Single Use and 4 other device types. 3 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2022.
6device types registered with the FDA
4products catalogued under its own name
4510(k) clearances
Registration
| Registered name | BOZHOU RONGJIAN MEDICAL APPLIANCE CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3023237645 |
| FEI number | 3023237645 |
| DUNS | 703044684 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 亳州融健医疗用品有限公司 |
|---|---|
| Unified social credit code | 91341622MA2T2JYR7D |
| Source | NMPA UDI database |
Location
| City | Bozhou |
|---|---|
| Province | Anhui |
| Address | Jianghuai Supply Base, Zhongkai Group, Mengcheng County |
| Postal code | 233500 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | Self-adhesive Electrode | 2022 | 47 |
| Lamp, Infrared, Therapeutic Heating | Class 2 | Infrared Lamp | 2024 | 235 |
| Needle, Acupuncture, Single Use | Class 2 | Seven-star Needles, Dry Needles, Sterile Acupuncture Needles | 2022 | 33 |
| Stimulator, Electro-Acupuncture | Class U | Needle Stimulator (Model: RJNS6-1) | 2022 | 2 |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | Class 2 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | 2023 | 32 |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | Class 2 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | 2025 | 57 |
Own-Brand Listings
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252688 | 2025-11-24 | NUH | Traditional | This company |
| K220578 | 2022-05-25 | GZJ | Traditional | This company |
| K220153 | 2022-03-18 | BWK | Traditional | This company |
| K213879 | 2022-01-05 | GXY | Traditional | This company |
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.