FDA Cleared

HiToP® is FDA cleared specifically for neuropothy and chronic pain. Both FDA approved and FDA cleared mean that the FDA has reviewed and “approved” the safety and efficacy of the device. Whether something is approved or cleared depends on the type of product or the regulatory pathway. For example pharmaceuticals, class 3 medical devices, and brand new energy technologies for specific conditions are usually FDA approved. Class 2 devices (which HiToP is) are often FDA cleared. The main different one is FDA registered - if something is FDA registered, the FDA did not review or "approve" the safety and efficacy. Normally Shockwave machines or massage devices, class 1 machines, are allowed to import just being FDA registered. 

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HiToP is advanced electrotherapy energy technology, and the FDA does recognize electrotherapy for chronic pain.

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There are some electrotherapy devices cleared by the FDA for chronic pain (broad application), but the HiToP surpasses them greatly in terms of efficiency. 

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To our knowledge, the HiToP is the only electrotherapy device specifically cleared for neuropathy, as well as broader chronic pain, and can be used for a wide range of other applications. HiToP also has over 13 published scientific papers on its use in neuropathy.

Non-invasive treatment

This is a non-invasive soulution that delivers therapeutic energy deep into the cells- without needles, incisions, or tissue disruption. 

Whole Body & Local

Versatile by design, HiToP® supports both whole-body applications for systmeic conditions and targeted treatments for localized areas.

What can HiToP Help With?

Chronic Sciatica, Neuropathic Pain, Chronic Radiating Pain, Muscle pain, Sports Recovery, And more

Clinically Proven

HiToP® is backed by a robust body of peer-reviewed scientific literature published in accredited medical journals, with all studies conducted on the HiTop® device.

Powerfully Gentle

Delivering power comparable to high-power laser therapy, HiTop® remains gentle and well-tolerated, with most patients experiencing only a subtle, comfortable tingling sensation.

Precision Controlled

Using patented frequency technology, HiToP® precisely targets a wide range of tissues at varying depths, allowing clinicians to address diverse conditions with comprehensive therapies.

HiToP Studies

HiToP® has been cleared for use by the FDA for chronic pain and Neuropathy, it has 13+ published papers on the treatment on neuropathy.  These studies can be found here. 

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HiToP® can provide lasting relief and help your body regulate the nervous system, energize cellular function, and support fascia and lymphatic flow. 

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HiToP has shown significant reduction in neuropathic pain socres, enhanced vascular repair, and significantly enhanced the function of microvascular endothelial cells in peer reviewed studies. 

In a study covering neuropathy for type 2 diabetes it showed a decline in HbA1c levels, significantly reduced burning sensations, improved sleep disturbances and improved neuropathy symptoms. 

In another study it was shown that short-term intervention over 5 days with HiToP has the potential to immediately reduce pain with a significantly stronger analgesic effect than TENS. 

The Study of Kerstine et al., 2018 demonstrated that a short term intervention over 5 days wit hHTEMS has the potential to immedicately reduce sciatic pain with a significantly stronger analgesic effect than TENS in middle-aged patients with chronic sciatica. 

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Additionaly, it increases vasodilation (enhanced bioavailability of nitric oxide) leading to improved microciculation and endoneural blood flow (locally and systemically)

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