The following data is part of a premarket notification filed by Hivox Biotek, Inc. with the FDA for Hivox Spopad Ems.
| Device ID | K141921 |
| 510k Number | K141921 |
| Device Name: | HIVOX SPOPAD EMS |
| 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 | Ke-min Jen |
| Correspondent | Ke-min Jen 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 | 2014-07-16 |
| Decision Date | 2015-01-16 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04719880810123 | K141921 | 000 |