# K251905: Normatec Elite Hip

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Sep 18, 2025 after 90 days
- Product code: IRP (Massager, Powered Inflatable Tube)
- Device class: 2
- Regulation: 21 CFR 890.5650
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 10 generations back to K850316 (1985). 21 ancestors in all.
No later device cites it as a predicate yet.
0 of 22 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240122: Normatec Elite, NormaTec Industries, LP (2024) Summary page 5.

## Indications for use
The Normatec Elite Hip is an air pressure massager intended to temporarily relieve minor muscle aches and/or pains, and to temporarily increase circulation to the treated areas.

Source page: https://510kreport.com/device/K251905
Methodology: https://510kreport.com/methodology