# K240178: RFG-01

- Pathway: 510(k) (Traditional)
- Applicant: Zimmer Medizinsysteme GmbH
- Decided: Jul 15, 2024 after 174 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: 4 generations back to K122389 (2012). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200359: NuEra Tight, NuEra Tight EMS, Bios S.R.L. (2020) Summary page 5.

## Indications for use
The RFG-01 is intended to: - provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. - provide, with a massage device, a temporary reduction in the appearance of cellulite.

Source page: https://510kreport.com/device/K240178
Methodology: https://510kreport.com/methodology