# K241733: Hebe (NP0000763)

- Pathway: 510(k) (Traditional)
- Applicant: Novasonix Technology S.L.
- Decided: Apr 16, 2025 after 303 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: 5 generations back to K122389 (2012). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210867: NuEra Tight RF, NuEra Tight RF Plus, Bios S.R.L. (2021) Summary page 6.

## Indications for use
HEBE is intended to provide topical heating to elevate tissue temperature for the treatment of selected medical conditions, including pain relief, muscle spasm reduction, and increased local circulation

Source page: https://510kreport.com/device/K241733
Methodology: https://510kreport.com/methodology