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 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08032625827559 | K061632 | 000 |
| 08032625827528 | K061632 | 000 |
| 08032625829782 | K061632 | 000 |
| 08032625829775 | K061632 | 000 |
| 08032625827566 | K061632 | 000 |
| 08032625827535 | K061632 | 000 |
| 08032625824183 | K061632 | 000 |
| 08032625824138 | K061632 | 000 |