Device Classification Name |
stimulator, muscle, powered, for muscle conditioning
|
510(k) Number |
K190038 |
Device Name |
Xbody Newave USA |
Applicant |
XBody Hungary Kft. |
Gyorgy Aladar u. 35-39 |
budapest,
HU
1125
|
|
Applicant Contact |
peter tar |
Correspondent |
Biomedical Regulatory Consulting |
9203 Hwy 6 South, Suite 124 |
houston,
TX
77083
|
|
Correspondent Contact |
r. william soller |
Regulation Number | 890.5850
|
Classification Product Code |
|
Date Received | 01/08/2019 |
Decision Date | 04/05/2019 |
Decision |
substantially equivalent
(SESE) |
Regulation Medical Specialty |
Physical Medicine
|
510k Review Panel |
Physical Medicine
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|