The following data is part of a premarket notification filed by Johari Digital Healthcare Ltd. with the FDA for Infrex.
Device ID | K060246 |
510k Number | K060246 |
Device Name: | INFREX |
Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
Applicant | JOHARI DIGITAL HEALTHCARE LTD. 7131 FARRALONE AVE, #48, Canoga Park, CA 91303 |
Contact | Pooja Johari |
Correspondent | Pooja Johari JOHARI DIGITAL HEALTHCARE LTD. 7131 FARRALONE AVE, #48, Canoga Park, CA 91303 |
Product Code | GZJ |
CFR Regulation Number | 882.5890 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-01-31 |
Decision Date | 2006-05-05 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08908008085284 | K060246 | 000 |
08908008085185 | K060246 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
INFREX 78484754 3197382 Live/Registered |
Medfaxx Inc. 2004-09-16 |
INFREX 75657434 not registered Dead/Abandoned |
INFREX LIMITED 1999-03-10 |