The following data is part of a premarket notification filed by Hi-dow International, Inc. with the FDA for Hi-dow Wireless Tens/ems System (model Hd-sn).
| Device ID | K163393 |
| 510k Number | K163393 |
| Device Name: | Hi-Dow Wireless TENS/EMS System (Model HD-SN) |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | Hi-Dow International, Inc. 2555 Metro Blvd Maryland Heights, MO 63043 |
| Contact | Eric Chen |
| Correspondent | Schevon G. Salmon Benjamin L. England & Associates, LLC 810 Landmark Drive, Suite 126 Glen Burnie, MD 21061 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-12-02 |
| Decision Date | 2017-08-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851640007467 | K163393 | 000 |
| 00851640007436 | K163393 | 000 |
| 00851640007429 | K163393 | 000 |
| 00851640007412 | K163393 | 000 |
| 00851640007405 | K163393 | 000 |
| 00851640007399 | K163393 | 000 |
| 00782944027014 | K163393 | 000 |