The following data is part of a premarket notification filed by Xbody Hungary Kft. with the FDA for Xbody Newave Usa.
| Device ID | K190038 |
| 510k Number | K190038 |
| Device Name: | Xbody Newave USA |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | XBody Hungary Kft. Gyorgy Aladar U. 35-39 Budapest, HU 1125 |
| Contact | Peter Tar |
| Correspondent | R. William Soller Biomedical Regulatory Consulting 9203 Hwy 6 South, Suite 124 Houston, TX 77083 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-08 |
| Decision Date | 2019-04-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05999860571001 | K190038 | 000 |