The following data is part of a premarket notification filed by Guangzhou Longest Science & Technology Co., Ltd. with the FDA for Portable Electro-stimulation Therapy Device.
| Device ID | K182108 |
| 510k Number | K182108 |
| Device Name: | Portable Electro-Stimulation Therapy Device |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Guangzhou Longest Science & Technology Co., Ltd. 5&6f, Building B4, No.11, Kaiyuan Avenue Science City Hi-Tech Industrial Zone Guangzhou, CN 510530 |
| Contact | Xiaobing Luo |
| Correspondent | You Yijie Qimmiq Medical Consulting Service Co., Ltd RM.1711, Building K, NO.101 Science Ave International Creative Valley Guangzhou, CN 510663 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-08-03 |
| Decision Date | 2019-04-26 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971410780049 | K182108 | 000 |