The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Lt3000 Combo Stimulator, Lt3001 Tens Stimulatory, Lt3002 Ems Stimulator.
Device ID | K100117 |
510k Number | K100117 |
Device Name: | LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR |
Classification | Stimulator, Muscle, Powered |
Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. ESTAE XILIXIAOBAIMANG Nanshan District, Shenzhen, CN 518108 |
Contact | Zhigang Zhao |
Correspondent | Marc M Mouser UNDERWRITERS LABORATORIES, INC. 2600 NW LAKE RD. Camas, WA 98607 -9526 |
Product Code | IPF |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2010-01-15 |
Decision Date | 2010-01-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
80092237618550 | K100117 | 000 |
80092237617515 | K100117 | 000 |
80092237616679 | K100117 | 000 |
80092237615900 | K100117 | 000 |