UltraTENS
Ultrasonic Diathermy 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 Ultratens.
Pre-market Notification Details
| Device ID | K142976 |
| 510k Number | K142976 |
| Device Name: | UltraTENS |
| Classification | Ultrasonic Diathermy For Use In Applying Therapeutic Deep Heat |
| Applicant | Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Industrial Estate Nanshan District Shenzhen, CN 518108 |
| Contact | Qilian Liu |
| Correspondent | Qilian Liu Shenzhen Dongdixin Technology Co., Ltd No. 3 Building, XiLiBaimang Industrial Estate Nanshan District Shenzhen, CN 518108 |
| Product Code | IMI |
| CFR Regulation Number | 890.5300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-14 |
| Decision Date | 2015-08-26 |
Trademark Results [UltraTENS]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ULTRATENS 86110658 4510927 Live/Registered |
COMPASS HEALTH BRANDS CORP. 2013-11-05 |
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