The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Sw-therm.
| Device ID | K131899 |
| 510k Number | K131899 |
| Device Name: | SW-THERM |
| Classification | Diathermy, Shortwave, 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 | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-06-25 |
| Decision Date | 2014-03-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00092237620397 | K131899 | 000 |