The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Comborehab.
| Device ID | K150436 |
| 510k Number | K150436 |
| Device Name: | ComboRehab |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. No. 3 Building XiliBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Contact | Jianping Kang |
| Correspondent | Jianping Kang SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. No. 3 Building XiliBaimang Xusheng Industrial Estate Nanshan Shenzhen, CN 518108 |
| Product Code | IMG |
| Subsequent Product Code | GZI |
| Subsequent Product Code | GZJ |
| Subsequent Product Code | HCC |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-02-19 |
| Decision Date | 2015-11-13 |
| Summary: | summary |