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FDA 510(k)

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)

K-Number: K202993 · 2023-05-15

ApplicantMmj Labs, LLC
Decision Date2023-05-15
Product CodePHW
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) is a medical device manufactured by Mmj Labs, LLC. It received FDA 510(k) clearance on 2023-05-15 under approval number K202993. The device is classified under product code PHW. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)?

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) is a medical device that received FDA 510(k) clearance on 2023-05-15. It is manufactured by Mmj Labs, LLC. The 510(k) number is K202993.

When was Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) approved by the FDA?

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) received FDA 510(k) clearance on 2023-05-15, under approval number K202993.

What company makes Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)?

Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) is manufactured by Mmj Labs, LLC.

What is the FDA product code for Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H)?

The FDA product code for Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal, Pro); VibraCool® (models: Easy Fit, Extended, Plantar, Flex, Pro DME, Pro UE, Pro LE, Pro 200H) is PHW.

Related Clinical Trials

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Related PubMed Literature

PMID: 41970523 Large language models in healthcare quality management: a European perspective on process automation and compliance. Frontiers in digital health (2026) PMID: 41966058 Artificial intelligence in personalized prescription: A narrative review of promise, peril, and practicality. Therapie (2026) PMID: 41857339 Innovating global regulatory frameworks for generative AI in medical devices is an urgent priority. NPJ digital medicine (2026) PMID: 41529615 Wearable microneedle sensors for continuous interstitial fluid monitoring. Biosensors & bioelectronics (2026)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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