Hivox Otc Electrical Stimulator, EM59-l, EM59-2
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K203574 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, Em59-L, Em59-2 is an electrical stimulator. It is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities and lower extremities due to strain from exercise or normal household work activities.
The device is supplied as a Transcutaneous Electrical Nerve Stimulator (Tens) and is intended for use in temporary relief of pain. It has been assigned the product code NUH and has received FDA 510K authorization with the decision code SESE and k number K203574.
Frequently asked questions
What is the Hivox OTC Electrical Stimulator used for?
The Hivox OTC Electrical Stimulator is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities and lower extremities due to strain from exercise or normal household work activities.
Is the Hivox OTC Electrical Stimulator a single-use device?
The description does not specify if the Hivox OTC Electrical Stimulator is single-use or reusable, but it is supplied as a Transcutaneous Electrical Nerve Stimulator (Tens).
What is the product code for the Hivox OTC Electrical Stimulator?
The Hivox OTC Electrical Stimulator has been assigned the product code NUH.
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, EM59-l, HIVOX OTC Electrical ..., HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC Electrical ..., HIVOX OTC Electrical Stimulator, EM59-l, HIVOX OTC… - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K203574 | Class II | Active |
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Manufacturer
- Manufacturer
- Hivox Biotek Inc.
- FDA Applicant
- Hivox Biotek, Inc.
Sources (1)
- FDA 510(k) K203574 24 fields · synced Sep 23, 2026