EM25 - glute toning device— 510(k) K143737
Substantially EquivalentHivox Biotek, Inc.
FDA 510(k) clearance K143737 for EM25 - glute toning device, Substantially Equivalent on 2015-07-27. Applicant: Hivox Biotek, Inc.. Device class: 2.
Clearance details
- Applicant
- Hivox Biotek, Inc.
- Product code
- Code NGX
- Device class
- Class 2
- Regulation
- 21 CFR 890.5850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- New Taipei City, TW
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