# 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)

- Pathway: 510(k) (Traditional)
- Applicant: Mmj Labs, LLC
- Decided: May 15, 2023 after 957 days
- Product code: PHW (Cold Pack And Vibrating Massager)
- Device class: 1
- Regulation: 21 CFR 890.5975
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K130631 (2014). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130631: BUZZY, Mmj Labs, LLC (2014) Summary page 4.

## Indications for use
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.

Source page: https://510kreport.com/device/K202993
Methodology: https://510kreport.com/methodology