HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2— 510(k) K092448
Substantially EquivalentHivox Biotek, Inc.
FDA 510(k) clearance K092448 for HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2, Substantially Equivalent on 2010-03-30. Applicant: Hivox Biotek, Inc.. Device class: 2.
Clearance details
- Applicant
- Hivox Biotek, Inc.
- Product code
- Code GZJ
- Device class
- Class 2
- Regulation
- 21 CFR 882.5890
- Advisory panel
- Neurology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taipei Hsien, TW
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