SensiFirm
Massager, Vacuum, Radio Frequency Induced Heat
EL Global Trade Ltd
The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Sensifirm.
Pre-market Notification Details
| 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 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060445341118 | K170637 | 000 |
Trademark Results [SensiFirm]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 SENSIFIRM 86072794 not registered Dead/Abandoned |
Derma Dream Group Ltd. 2013-09-24 |
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