The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Sensifirm.
Device ID | K170637 |
510k Number | K170637 |
Device Name: | SensiFirm |
Classification | Massager, Vacuum, Radio Frequency Induced Heat |
Applicant | EL Global Trade Ltd 8 Tzoran St, P.O. Box 8242 Netanya, IL 4250608 |
Contact | Yael Liebes |
Correspondent | Yael Liebes EL Global Trade Ltd 8 Tzoran St, P.O. Box 8242 Netanya, IL 4250608 |
Product Code | PBX |
CFR Regulation Number | 878.4400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-03-02 |
Decision Date | 2017-07-14 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05060445341118 | K170637 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
SENSIFIRM 98733962 not registered Live/Pending |
Zhengzhou Yanche Technology Co., Ltd. 2024-09-05 |
SENSIFIRM 86072794 not registered Dead/Abandoned |
Derma Dream Group Ltd. 2013-09-24 |