The following data is part of a premarket notification filed by Shenzhen Jumper Medical Equipment Co., Ltd. with the FDA for Mini Tens Therapy Device.
| Device ID | K182871 |
| 510k Number | K182871 |
| Device Name: | Mini TENS Therapy Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Jumper Medical Equipment Co., Ltd. D Building, No. 71, Xintian Road, Fuyong Street, Baoan, Shenzhen, CN 518100 |
| Contact | Tom Tom |
| Correspondent | Reanny Wang Shenzhen Reanny Medical Devices Management Consulting Co Ltd Room 2012#,Gebu Commercial Building, Hongxing Community, Songgang Street, Shenzhen, CN 518000 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-10-12 |
| Decision Date | 2019-08-01 |