# K240122: Normatec Elite

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Mar 21, 2024 after 65 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: 9 generations back to K850316 (1985). 20 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220217: Normatec 3, NormaTec Industries, LP (2022) Summary page 5.

## Most influential descendants
- K251905: Normatec Elite Hip (2025), 0 descendants of its own
- K243206: Air compression massager (ACM-PLUS-A1, ACM-PLUS-A2, ACM-PLUS-A3, ACM-PLUS-A4, ACM-PLUS-A5, ACM-PLUS-A6) (2025), 0 descendants of its own
- K241446: Air Compression Massager (ACM-A1, ACM-A2, ACM-A3, ACM-A4) (2024), 0 descendants of its own

## Indications for use
The Normatec Elite 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/K240122
Methodology: https://510kreport.com/methodology