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 |