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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 the device name listed in this FDA 510(k) record. The listed applicant is Mmj Labs, LLC. It received FDA 510(k) clearance on 2023-05-15 under 510(k) 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. The listed applicant is Mmj Labs, LLC. The 510(k) number is K202993.

When did 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) receive FDA 510(k) clearance?

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 510(k) number K202993.

Who is the listed applicant 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 510(k) record lists Mmj Labs, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Official Source

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

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