The following data is part of a premarket notification filed by Hivox Biotek Inc. with the FDA for Hivox Spopad Ems Sp-911, Sp-921.
| Device ID | K192264 |
| 510k Number | K192264 |
| Device Name: | HIVOX Spopad EMS SP-911, SP-921 |
| Classification | Stimulator, Muscle, Powered, For Muscle Conditioning |
| Applicant | Hivox Biotek Inc. 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City, TW 24158 |
| Contact | Marx Lee |
| Correspondent | Marx Lee Hivox Biotek Inc. 5F., No. 123, Xinde Rd. Sanchong Dist. New Taipei City, TW 24158 |
| Product Code | NGX |
| CFR Regulation Number | 890.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-21 |
| Decision Date | 2019-11-08 |