The following data is part of a premarket notification filed by Johari Digital Healthcare, Ltd. with the FDA for Product Line-combo Stimulator/sequential Stimulator, Model If-5000.
| Device ID | K024036 |
| 510k Number | K024036 |
| Device Name: | PRODUCT LINE-COMBO STIMULATOR/SEQUENTIAL STIMULATOR, MODEL IF-5000 |
| Classification | Stimulator, Muscle, Powered |
| Applicant | JOHARI DIGITAL HEALTHCARE, LTD. EC-1,2, 3 ELECTRONIC COMPLEX LIGHT INDUSTRIAL AREA Jodhpur, Raj, IN 342003 |
| Contact | Nisha Johari |
| Correspondent | Nisha Johari JOHARI DIGITAL HEALTHCARE, LTD. EC-1,2, 3 ELECTRONIC COMPLEX LIGHT INDUSTRIAL AREA Jodhpur, Raj, IN 342003 |
| Product Code | IPF |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-12-06 |
| Decision Date | 2002-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 80092237612619 | K024036 | 000 |
| 00858688006117 | K024036 | 000 |
| 00858688006032 | K024036 | 000 |
| 08908008085338 | K024036 | 000 |
| 08908008085239 | K024036 | 000 |
| 08908008085222 | K024036 | 000 |
| 08908008085116 | K024036 | 000 |
| 08908008085109 | K024036 | 000 |