The following data is part of a premarket notification filed by Hi-dow International Inc. with the FDA for Hi-dow-xp.
| Device ID | K102598 |
| 510k Number | K102598 |
| Device Name: | HI-DOW-XP |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | HI-DOW INTERNATIONAL INC. 2071 CONGRESSIONAL DR St Louis, MO 63146 |
| Contact | Eric Chen |
| Correspondent | Eric Chen HI-DOW INTERNATIONAL INC. 2071 CONGRESSIONAL DR St Louis, MO 63146 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-10 |
| Decision Date | 2011-05-13 |
| Summary: | summary |