The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Laser-stim.
Device ID | K131259 |
510k Number | K131259 |
Device Name: | LASER-STIM |
Classification | Lamp, Infrared, Therapeutic Heating |
Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
Contact | Jiangping Kang |
Correspondent | Jiangping Kang SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
Product Code | ILY |
CFR Regulation Number | 890.5500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-05-02 |
Decision Date | 2013-12-27 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
80092237621055 | K131259 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
LASER-STIM 75010967 2102016 Live/Registered |
LASERSTIM, INC. 1995-10-26 |