The following data is part of a premarket notification filed by Guangzhou Longest Science & Technology Co., Ltd. with the FDA for Compression Therapy Device Model Lgt-2200sp.
| Device ID | K191862 |
| 510k Number | K191862 |
| Device Name: | Compression Therapy Device Model LGT-2200SP |
| Classification | Massager, Powered Inflatable Tube |
| 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 | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-11 |
| Decision Date | 2019-10-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06971410780100 | K191862 | 000 |