SW-THERM

Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat

SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD.

The following data is part of a premarket notification filed by Shenzhen Dongdixin Technology Co, Ltd. with the FDA for Sw-therm.

Pre-market Notification Details

Device IDK131899
510k NumberK131899
Device Name:SW-THERM
ClassificationDiathermy, 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
ContactJianping Kang
CorrespondentJianping Kang
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. No. 3 Building XiliBaimang Xusheng Industrial Estate Nanshan Shenzhen,  CN 518108
Product CodeIMJ  
CFR Regulation Number890.5290 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-06-25
Decision Date2014-03-14

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00092237620397 K131899 000

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