The following data is part of a premarket notification filed by El Global Trade Ltd with the FDA for Rf-relief.
Device ID | K181095 |
510k Number | K181095 |
Device Name: | RF-Relief |
Classification | Massager, Vacuum, Radio Frequency Induced Heat |
Applicant | EL Global Trade Ltd 8 Tzoran St, P.O. Box 8242 Netanya, IL 4250608 |
Contact | Martin Gurovich |
Correspondent | Martin Gurovich 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 | 2018-04-26 |
Decision Date | 2018-07-24 |
Summary: | summary |