The following data is part of a premarket notification filed by Shenzhen Leading Perfection Technology Co., Ltd with the FDA for Electronic Pulse Stimulator.
| Device ID | K183674 |
| 510k Number | K183674 |
| Device Name: | Electronic Pulse Stimulator |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Shenzhen Leading Perfection Technology Co., Ltd 4th Floor, J Building, San Yi Dui Industrial Park, Zhoushi Road, Jiuwei Shenzhen, CN 518101 |
| Contact | Simon Hou |
| Correspondent | Rain Yip Feiying Drug & Medical Consulting Technical Service Group Rm. 3005, Area B, Bldg.1, Southward Ruifeng Business Center, Guimiao Road 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 | 2018-12-27 |
| Decision Date | 2019-10-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06973209160087 | K183674 | 000 |
| 06973209160056 | K183674 | 000 |
| 06973209160049 | K183674 | 000 |
| 06973209160032 | K183674 | 000 |
| 06973209160025 | K183674 | 000 |