Hivox Otc Electrical Stimulator
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190347 FDA 510(k)
- FDA Product Code
- NUH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.5890 FDA 510(k)
- Regulation Number
- 882.5890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Hivox Otc Electrical Stimulator is a transcutaneous electrical nerve stimulation (TENS) device designed for the temporary relief of pain. It targets sore and aching muscles in the shoulder, waist, back, neck, upper and lower extremities, abdomen, and bottom caused by strain from exercise or normal household activities.
This device is authorized under FDA 510(k) clearance. It is available in multiple models, including the SEM44-1, EM59-1, and the Rapid Relief Pennypad PP-904.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: HIVOX OTC Electrical Stimulator (K171803) — FDA 510 (k) | Innolitics, HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical ..., HIVOX ELECTRIC STIMULATOR OTC TENS by HIVOX BIOTEK, INC. | FDA 510(k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190347 | Class II | Active |
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Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- FDA Applicant
- Hivox Biotek, Inc.
Sources (1)
- FDA 510(k) K190347 24 fields · synced Sep 24, 2026