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, Model: Lgt-232(us).
| Device ID | K201845 |
| 510k Number | K201845 |
| Device Name: | Portable Electro-Stimulation Therapy Device, Model: LGT-232(US) |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Guangzhou Longest Science & Technology Co., LTD. 5 & 6f, Building B4, No. 11, Kaiyuan Avenue, Science City Guangzhou, CN 510530 |
| Contact | Xiaobing Luo |
| Correspondent | Jet Li Guangzhou KEDA Biological Tech Co., LTD. 6F, No. 1 TianTai Road, Science City, LuoGang District Guangzhou, CN |
| Product Code | NGX |
| Subsequent Product Code | NUH |
| Subsequent Product Code | NYN |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-06 |
| Decision Date | 2020-10-08 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971410780032 | K201845 | 000 |