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 |