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 |