FDA 510(k)
FDA class 2
Substantially Equivalent
🇹🇼 Taiwan
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
K Number: K092448
·
Decision Mar 30, 2010
Classifications
1
FEI Numbers
184
Registration Numbers
184
Same Product Code
605
Applicant Total
18
Review Days
232
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Basic Information
- Device Name
- HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2
- K Number
- K092448
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.5890
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hivox Biotek, Inc.
- Date Received
- August 10, 2009
- Decision Date
- March 30, 2010
- Product Code
- GZJ
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | FDA class 2 | Neurology |
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Other Clearances by Hivox Biotek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K260425 | TENS / EMS DEVICE (FT-247 Series) (FT-247, FT-237) | Jun 16, 2026 | Substantially Equivalent |
| K242815 | POCKET TENS (EP-300) | Dec 17, 2024 | Substantially Equivalent |
| K232675 | Heating Tens, FT-615 | Oct 5, 2023 | Substantially Equivalent |
| K223308 | HEATING TENS/EMS, FT-810R | May 13, 2023 | Substantially Equivalent |
| K221384 | Heating TENS/EMS Device, FT-240-1, Heating TENS/EMS Device, FT-240-2 | Jun 11, 2022 | Substantially Equivalent |
| K211403 | HIVOX OTC Electrical Stimulator, FT610-B | Oct 15, 2021 | Substantially Equivalent |
| K203574 | HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical Stimulator, EM59-2 | Mar 10, 2021 | Substantially Equivalent |
| K192264 | HIVOX Spopad EMS SP-911, SP-921 | Nov 8, 2019 | Substantially Equivalent |
| K190347 | HIVOX OTC Electrical Stimulator | Mar 15, 2019 | Substantially Equivalent |
| K171803 | HIVOX OTC Electrical Stimulator | Nov 29, 2017 | Substantially Equivalent |