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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 09351609000023 | K102598 | 000 |
| 00851640007108 | K102598 | 000 |
| 00851640007115 | K102598 | 000 |
| 00851640007122 | K102598 | 000 |
| 00851640007139 | K102598 | 000 |
| 00851640007146 | K102598 | 000 |
| 00851640007153 | K102598 | 000 |
| 00851640007160 | K102598 | 000 |
| 00851640007177 | K102598 | 000 |
| 00851640007092 | K102598 | 000 |
| 00851640007085 | K102598 | 000 |
| 00851640007078 | K102598 | 000 |
| 00846362080171 | K102598 | 000 |
| 00851640007009 | K102598 | 000 |
| 00851640007016 | K102598 | 000 |
| 00851640007023 | K102598 | 000 |
| 00851640007030 | K102598 | 000 |
| 00851640007047 | K102598 | 000 |
| 00851640007054 | K102598 | 000 |
| 00851640007061 | K102598 | 000 |
| 00851640007207 | K102598 | 000 |
| 00851640007214 | K102598 | 000 |
| 00851640007351 | K102598 | 000 |
| 00851640007368 | K102598 | 000 |
| 00851640007375 | K102598 | 000 |
| 00851640007443 | K102598 | 000 |
| 00851640007450 | K102598 | 000 |
| 00851640007474 | K102598 | 000 |
| 00782944027007 | K102598 | 000 |
| 00799439774018 | K102598 | 000 |
| 00851640007344 | K102598 | 000 |
| 00851640007337 | K102598 | 000 |
| 00851640007320 | K102598 | 000 |
| 00851640007221 | K102598 | 000 |
| 00851640007238 | K102598 | 000 |
| 00851640007245 | K102598 | 000 |
| 00851640007269 | K102598 | 000 |
| 00851640007276 | K102598 | 000 |
| 00851640007283 | K102598 | 000 |
| 00851640007306 | K102598 | 000 |
| 00851640007313 | K102598 | 000 |
| 00799439774025 | K102598 | 000 |