# K130631: BUZZY

- Pathway: 510(k) (Traditional)
- Applicant: Mmj Labs, LLC
- Decided: Aug 13, 2014 after 523 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- 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) (2023), 0 descendants of its own

## Indications for use
Control pain associated with injections, venipuncture, IV starts, cosmetic injections and the temporary relief of minor injuries (muscle or tendon aches, splinters and bee stings). Also intended to treat myofascial pain caused by trigger points, restricted motion and muscle tension

Source page: https://510kreport.com/device/K130631
Methodology: https://510kreport.com/methodology