ALEVE Direct Therapy TENS Device
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K152852 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 ALEVE Direct Therapy TENS Device is a transcutaneous electrical nerve stimulation (TENS) unit designed to provide drug-free pain relief. It delivers electrical pulses through the skin to modulate pain signals, targeting lower back discomfort caused by muscle soreness or aching. The device employs patented waveform technology to achieve deep, penetrating relief by interfering with pain transmission pathways in the body.
This non-invasive device is intended for home use and is supplied as a single-use or reusable system, depending on the electrode pads included. It is not classified as sterile and is regulated under FDA 510(k) clearance (K152852) as substantially equivalent to existing TENS devices. The device operates outside MRI environments and requires no special storage conditions. Authorised for pain management in musculoskeletal applications, it adheres to FDA guidelines for electrical stimulation devices.
Frequently asked questions
What is the ALEVE Direct Therapy TENS device used for?
The ALEVE Direct Therapy TENS device is designed to provide drug-free pain relief for lower back discomfort caused by muscle soreness or aching. It works by delivering electrical pulses through the skin to interfere with pain signals, targeting the specific pathways responsible for transmitting discomfort. This non-invasive approach is ideal for managing musculoskeletal pain at home without medication.
Is the ALEVE Direct Therapy TENS device single-use or reusable?
The ALEVE Direct Therapy TENS device can be supplied with either single-use or reusable electrode pads, depending on the specific model or configuration. If reusable pads are included, they should be cleaned and stored properly between uses to maintain hygiene and functionality. Always check the packaging or instructions for the type of pads included with your device.
Does the ALEVE Direct Therapy TENS device require special storage conditions?
No, the ALEVE Direct Therapy TENS device does not require any special storage conditions. It can be stored at room temperature, away from direct sunlight, moisture, and extreme temperatures. Proper storage ensures the device remains functional and safe for use when needed.
Can the ALEVE Direct Therapy TENS device be used in an MRI environment?
No, the ALEVE Direct Therapy TENS device is not designed for use in MRI environments. Electrical stimulation devices like this one can interfere with MRI equipment or pose safety risks during imaging procedures. Always consult with medical staff if you need to use this device in a clinical setting where MRI scans are performed.
What regulatory clearance does the ALEVE Direct Therapy TENS device hold?
The ALEVE Direct Therapy TENS device holds FDA 510(k) clearance under the reference number K152852. This clearance categorizes it as substantially equivalent to existing TENS devices, meaning it meets the regulatory standards for electrical stimulation devices intended for pain management in musculoskeletal applications. The device adheres to FDA guidelines for such products.
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: Aleve Direct Therapy - TENS Device - amazon.com, Aleve Direct Therapy TENS Device Value Pack (1 Device + 2 ... - Amazon, Bayer Healthcare Aleve Direct Therapy Tens Device 1 kit
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K152852 | Class II | Active |
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Manufacturer
- Manufacturer
- Bayer HealthCare, LLC
Sources (1)
- FDA 510(k) K152852 24 fields · synced Oct 5, 2026