NeuroMetrix has obtained FDA’s DeNovo clearance on its latest version of Quell wearable, the Quell-FM. The Quell line of products helps with chronic pain relief.
NeuroMetrix is a commercial-stage company that was founded as a spinoff from the Harvard-MIT Division of Health Sciences and Technology.
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The Quell-FM device is a transcutaneous electrical nerve stimulator to treat fibromyalgia symptoms.
The Quell product is a wearable neurostimulation technology that is completely automated and works seamlessly with your smartphone or Apple Watch.
The device supports Bluetooth® low energy (BLE) to communicate with the Quell app, which is available for iOS and Android mobile devices.
Just place Quell on your upper calf and go about your day or go to sleep and let the prescription strength pain relief do the rest.
Quell stimulates sensory nerves with safe and precise electrical pulses to trigger a natural pain relief response.
The impact of chronic pain extends beyond the direct experience of pain intensity to its impact on daily function and quality of life.
Quell has been granted Breakthrough Device Designation by the FDA for the treatment of fibromyalgia symptoms in adults.
For users who may experience pain with changing weather, the Quell app will even alert you when the weather is likely to aggravate your pain and suggest an alternative dose for the day.
The Quell 2.0 currently sells for $299. If you are in the market for a TENS unit that is easy to use, FDA approved, and can be easily controlled via your Apple Watch or iPhone, this may be a good option.
We could not find documentation around the new Quell-FM device. The company seems to be selling the Quell 2.0 currently on its website and Amazon.