# K211207: Diacare 7000

- Pathway: 510(k) (Traditional)
- Applicant: Globus Sport and Health Technologies, LLC
- Decided: Jun 6, 2022 after 410 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K122389 (2012). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162828: Winback Back 3SE, Winback USA Corp (2017) Summary page 4.

## Indications for use
The Diacare 7000 is intended to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.

Source page: https://510kreport.com/device/K211207
Methodology: https://510kreport.com/methodology