The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Ct2011 Sonicstimu Pain Relief Device.
| Device ID | K092627 |
| 510k Number | K092627 |
| Device Name: | CT2011 SONICSTIMU PAIN RELIEF DEVICE |
| Classification | Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat |
| Applicant | SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Contact | Zhignag Zhao |
| Correspondent | Zhignag Zhao SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. XILIXIAOBAIMANG Shenzhen, Guangdong, CN 518108 |
| Product Code | IMG |
| CFR Regulation Number | 890.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-08-26 |
| Decision Date | 2010-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237618864 | K092627 | 000 |
| 80092237616808 | K092627 | 000 |
| 80092237611667 | K092627 | 000 |
| 80092237611650 | K092627 | 000 |
| 80092237611636 | K092627 | 000 |
| 80092237611568 | K092627 | 000 |
| 80092237611544 | K092627 | 000 |