The following data is part of a premarket notification filed by International Trade Group, Inc. with the FDA for Xiniwave Ii Model Ecs322p.
| Device ID | K171092 |
| 510k Number | K171092 |
| Device Name: | XiniWave II Model ECS322P |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | International Trade Group, Inc. 4663 Katie Lane Oxford, OH 45056 |
| Contact | Brent C. Reider |
| Correspondent | Brent C. Reider International Trade Group, Inc. 4663 Katie Lane Oxford, OH 45056 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-04-12 |
| Decision Date | 2017-07-10 |
| Summary: | summary |