The following data is part of a premarket notification filed by Johari Digital Healthcare, Ltd. with the FDA for Cranial Electrical Nerve Stimulator, Model Fm 10/c.
| Device ID | K090052 |
| 510k Number | K090052 |
| Device Name: | CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C |
| Classification | Stimulator, Cranial Electrotherapy |
| Applicant | JOHARI DIGITAL HEALTHCARE, LTD. ELECTRONIC HARDWARE TECHNOLOGY PARK, G-582, 583, E.P.I.P Boranada, Jodhpur, Rajasthan, IN 342008 |
| Contact | Nisha Johari |
| Correspondent | Nisha Johari JOHARI DIGITAL HEALTHCARE, LTD. ELECTRONIC HARDWARE TECHNOLOGY PARK, G-582, 583, E.P.I.P Boranada, Jodhpur, Rajasthan, IN 342008 |
| Product Code | JXK |
| CFR Regulation Number | 882.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-07 |
| Decision Date | 2009-05-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085321 | K090052 | 000 |
| 08908008085314 | K090052 | 000 |
| 08908008085208 | K090052 | 000 |
| 08908008085086 | K090052 | 000 |
| 08908008085383 | K090052 | 000 |
| 08908008085406 | K090052 | 000 |