The following data is part of a premarket notification filed by Guangzhou Longest Science & Technology Co., Ltd. with the FDA for Mstim Drop Model: Lgt-233.
| Device ID | K202110 |
| 510k Number | K202110 |
| Device Name: | MStim Drop Model: LGT-233 |
| Classification | Stimulator, Neuromuscular, External Functional |
| Applicant | Guangzhou Longest Science & Technology CO., Ltd. 5&6F, Building B4, No.11, Kaiyuan Avenue, Science City, Guangzhou Hi-tech In Guangzhou, CN 510530 |
| Contact | Xiaobing Luo |
| Correspondent | Jet Li Guangzhou Keda Biological Tech Co., Ltd. 6F, No. I TianTai Road, Science City, LuoGang District Guangzhou, CN 510060 |
| Product Code | GZI |
| CFR Regulation Number | 882.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-07-30 |
| Decision Date | 2021-11-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971410780063 | K202110 | 000 |
| 00692520001133 | K202110 | 000 |
| 00692520001126 | K202110 | 000 |
| 00692520001119 | K202110 | 000 |
| 00692520001027 | K202110 | 000 |
| 06976287180824 | K202110 | 000 |