The following data is part of a premarket notification filed by Johari Electro-tech Co. with the FDA for Analgesic Pulser, Model Ap-439.
| Device ID | K993229 |
| 510k Number | K993229 |
| Device Name: | ANALGESIC PULSER, MODEL AP-439 |
| Classification | Stimulator, Nerve, Transcutaneous, For Pain Relief |
| Applicant | JOHARI ELECTRO-TECH CO. VANDANA, 28 NEHRU PARK, Jodhpur-342003, IN 342003 |
| Contact | Nisha Johari |
| Correspondent | Nisha Johari JOHARI ELECTRO-TECH CO. VANDANA, 28 NEHRU PARK, Jodhpur-342003, IN 342003 |
| Product Code | GZJ |
| Subsequent Product Code | IPF |
| Subsequent Product Code | LIH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 1999-09-27 |
| Decision Date | 2001-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08908008085178 | K993229 | 000 |
| 08908008085154 | K993229 | 000 |