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 |