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Is Joylux FDA Approved?

Published in FDA Device Classification 4 mins read

Joylux's vFit and vFit PLUS devices are not "FDA approved" in the traditional sense of a cleared or approved medical device. Instead, these products have been designated by the FDA as Low-Risk General Wellness Devices, meaning they are legally marketed.

Understanding the FDA Designation for Joylux Products

In early 2017, Joylux submitted its vFit and vFit PLUS devices to the U.S. Food and Drug Administration (FDA) to determine their appropriate device classification. Following a comprehensive review of the devices' claims and technological characteristics, the FDA designated vFit and vFit PLUS as Low-Risk General Wellness Devices.

This designation is distinct from the FDA clearance (e.g., 510(k) clearance for moderate-risk devices) or FDA approval (for high-risk devices like Class III devices requiring a Premarket Approval (PMA)). For general wellness devices, the FDA does not require premarket clearance or approval because they pose a low risk to users and are intended for general wellness purposes.

What Does "Low-Risk General Wellness Device" Mean?

The FDA's classification of a product as a Low-Risk General Wellness Device indicates several key points, based on the agency's guidance for such products:

  • Intended Use: The device is intended for general wellness use, which typically relates to maintaining or encouraging a general state of health or a healthy activity. These devices do not make claims to diagnose, cure, mitigate, treat, or prevent disease.
  • Low Risk: The device presents a low risk to the safety of users. This is a crucial criterion for this classification.
  • No Premarket Review Required: Unlike many medical devices, these devices do not require a 510(k) premarket notification or Premarket Approval (PMA) from the FDA before being marketed.
  • Legally Marketed: While not "approved" or "cleared" through the medical device pathway, the designation confirms that the devices can be legally sold in the United States under this specific classification.

This classification allows manufacturers to introduce products aimed at general well-being without undergoing the extensive regulatory processes required for medical devices that make specific medical claims or pose higher risks.

Key Distinctions in FDA Oversight for Devices

It's important to differentiate between various levels of FDA oversight for devices, as the term "FDA approved" can be misleading when applied broadly:

FDA Status Description Relevance to Joylux vFit/vFit PLUS
FDA Approved (PMA) Highest level of FDA scrutiny for Class III medical devices; requires extensive scientific evidence of safety and effectiveness through a Premarket Approval (PMA) application. Not applicable; vFit/vFit PLUS are not Class III devices.
FDA Cleared (510(k) Notification) For Class I and II medical devices; demonstrates substantial equivalence to a legally marketed predicate device through a 510(k) premarket notification. Not applicable; vFit/vFit PLUS are not 510(k) cleared medical devices.
FDA Designated Low-Risk General Wellness Device Devices intended for general wellness, posing a low risk to safety, and not claiming to treat or diagnose medical conditions. No premarket review (510(k) or PMA) is required. See the FDA's General Wellness Policy for Low-Risk Devices for more details. This is the specific designation for Joylux vFit/vFit PLUS. They are legally marketed under this policy.

Joylux's vFit and vFit PLUS fall into the last category, signifying their recognized status as legally marketed devices under the FDA's general wellness policy.

Conclusion

Joylux's vFit and vFit PLUS devices are recognized by the FDA as legally marketed Low-Risk General Wellness Devices. This means they have undergone an FDA classification review and meet the criteria for devices that pose a low risk to users and are intended for general wellness purposes, allowing them to be sold without requiring traditional premarket clearance or approval.