The following data is part of a premarket notification filed by Global Marketing Partners Dba Gymmax Usa with the FDA for Butterfly Toner Model Gym070.
| Device ID | K093368 |
| 510k Number | K093368 |
| Device Name: | BUTTERFLY TONER MODEL GYM070 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | GLOBAL MARKETING PARTNERS DBA GYMMAX USA 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
| Contact | Nicolaas Besseling |
| Correspondent | Nicolaas Besseling GLOBAL MARKETING PARTNERS DBA GYMMAX USA 28711 JAEGER DRIVE Laguna Niguel, CA 92677 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-10-29 |
| Decision Date | 2010-01-27 |
| Summary: | summary |