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 |