The following data is part of a premarket notification filed by Domino S.r.l. with the FDA for Globus Premium Muscle Stimulator.
Device ID | K061632 |
510k Number | K061632 |
Device Name: | GLOBUS PREMIUM MUSCLE STIMULATOR |
Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
Applicant | DOMINO S.R.L. 18 EUSTACE DRIVE West Hartford, CT 06110 |
Contact | Giovanni Ciriani |
Correspondent | Giovanni Ciriani DOMINO S.R.L. 18 EUSTACE DRIVE West Hartford, CT 06110 |
Product Code | NGX |
CFR Regulation Number | 890.5850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-06-12 |
Decision Date | 2007-04-30 |
Summary: | summary |