Device Classification Name |
massager, powered inflatable tube
|
510(k) Number |
K191862 |
Device Name |
Compression Therapy Device Model LGT-2200SP |
Applicant |
Guangzhou Longest Science & Technology Co., Ltd. |
5&6f, Building B4, No.11, Kaiyuan Avenue, Science City |
Guangzhou,
CN
510530
|
|
Applicant Contact |
Xiaobing Luo |
Correspondent |
Guangzhou KEDA Biological Tech Co., Ltd. |
6F, No.1 TianTai road, Science City, LuoGang District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 890.5650
|
Classification Product Code |
|
Date Received | 07/11/2019 |
Decision Date | 10/29/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|