The following data is part of a premarket notification filed by Bozhou Rongjian Medical Appliance Co.,ltd. with the FDA for Transcutaneous Electrical Nerve Stimulator (model Rjtens-1).
| Device ID | K220578 |
| 510k Number | K220578 |
| Device Name: | Transcutaneous Electrical Nerve Stimulator (Model RJTENS-1) |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, CN 233500 |
| Contact | Wu Zhifang |
| Correspondent | Wu Zhifang Bozhou Rongjian Medical Appliance Co.,Ltd. Jianghuai Supply Base, Zhongkai Group, Mengcheng County Bozhou, CN 233500 |
| Product Code | GZJ |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-28 |
| Decision Date | 2022-05-25 |