510(k) · Cleared
ClearedBuzzy® (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)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mmj Labs, LLC · PHW Cold Pack And Vibrating Massager
Cleared on May 15, 2023 as substantially equivalent to K130631 (Mmj Labs, LLC, 2014) after a 957-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- May 15, 2023
- Review
- 957 days
- Class
- Class I
- Product code
- PHW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K130631 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK130631 BUZZYMmj Labs, LLC · 2014
- This deviceK202993 Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL…Mmj Labs, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K130631 | BUZZY | Mmj Labs, LLC | 2014 | — |
| 0 (this device) | K202993 | Buzzy® (models: Mini Healthcare, XL Healthcare, Mini Personal, XL Personal… | Mmj Labs, LLC | 2023 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in PHW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K130631 | BUZZYSummary page 4…Class I / 510(k) Exempt) PREDICATE DEVICE IDENTIFICATION 510(k) Number Predicate Device Trade Name Manufacturer K130631 Buzzy® MMJ Labs, LLC 510(k) Summary DEVICE D… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
How does its category compare?
All PHW devicesPHW Cold Pack And Vibrating Massager: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · PHW
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · PHW
Too few PHW 510(k)s in any year since 2007 to give a median.
Recalls per year · PHW
No recall names PHW since 2007.
Adverse event reports per year · PHW
No MAUDE report names PHW since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 1 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Buzzy® is intended to control pain associated with needle procedures (e.g., injections, vascular access, cannulation, lab draws, blood donation, dialysis, cosmetic and dental injections) and the temporary relief of minor injuries (muscle or tendon aches, splinters, and bee stings).
VibraCool® is intended for the temporary relief of minor injuries (muscle or tendon aches) and the treatment of myofascial pain post-surgery. It is also indicated for use prior to or during physical therapy to treat myofascial pain caused by trigger points, restricted motion and muscle tension.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K202993 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202993: 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).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202993
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026