The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Xiniwave, Model Xw-18.
| Device ID | K100441 |
| 510k Number | K100441 |
| Device Name: | XINIWAVE, MODEL XW-18 |
| Classification | Stimulator, Nerve, Transcutaneous, Over-the-counter |
| Applicant | INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. Oxford, OH 45056 |
| Contact | Brent C Reider |
| Correspondent | Brent C Reider INTERNATIONAL TRADE GROUP, INC. 4663 KATIE LN. Oxford, OH 45056 |
| Product Code | NUH |
| CFR Regulation Number | 882.5890 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-02-17 |
| Decision Date | 2010-07-15 |
| Summary: | summary |