The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Em25 - Glute Toning Device.
| Device ID | K143737 |
| 510k Number | K143737 |
| Device Name: | EM25 - Glute Toning Device |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | HIVOX BIOTEK, INC. 5 F., NO. 123, Shingde Road San-chong District New Taipei City, TW 24158 |
| Contact | Clytie Chiou |
| Correspondent | Clytie Chiou HIVOX BIOTEK, INC. 5 F., NO. 123, Shingde Road San-chong District New Taipei City, TW 24158 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-30 |
| Decision Date | 2015-07-27 |
| Summary: | summary |