Data / Medical devices / China / Bozhou Rongjian Medical Appliance Co., Ltd.
Bozhou Rongjian Medical Appliance Co., Ltd.: FDA-registered device maker in Bozhou Anhui, China, 4 510(k) clearances
Bozhou Rongjian Medical Appliance Co., Ltd. is registered with the FDA (registration 3023237645) in Bozhou Anhui, China. It lists 6 device types. The FDA files 4 510(k) clearances under its listings, the newest dated November 24, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3023237645
- Address
- Jianghuai Supply Base, Zhongkai Group, Mengcheng County, Bozhou Anhui, China, 233500
- Owner or operator
- Bozhou Rongjian Medical Appliance Co., Ltd. (10084937)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- April 17, 2022
- Registered through
- 2026
- Brand names listed
- Dry Needles, Infrared Lamp, Needle Stimulator (Model: RJNS6-1), Self-adhesive Electrode, Seven-star Needles, Sterile Acupuncture Needles, Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1), Transcutaneous Electrical Nerve Stimulator (RJTENS-2)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Needle, Acupuncture, Single Use | MQX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Electro-Acupuncture | BWK | U | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, For Pain Relief | GZJ | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| November 24, 2025 | K252688 | Transcutaneous Electrical Nerve Stimulator (RJTENS-2) | NUH | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co., Ltd. | accessdata.fda.gov |
| May 25, 2022 | K220578 | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) | GZJ | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co., Ltd. | accessdata.fda.gov |
| March 18, 2022 | K220153 | Needle Stimulator (Model: RJNS6-1) | BWK | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co., Ltd. | accessdata.fda.gov |
| January 5, 2022 | K213879 | Self-adhesive Electrode | GXY | Substantially Equivalent | Bozhou Rongjian Medical Appliance Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Electro-Acupuncture
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Stimulator, Nerve, Transcutaneous, For Pain Relief
- All makers of Needle, Acupuncture, Single Use
- All makers of Electrode, Cutaneous
Updated November 24, 2025. 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.