# K220217: Normatec 3

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Feb 25, 2022 after 30 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: 8 generations back to K850316 (1985). 19 ancestors in all.
7 later devices descend from it; 2 cite it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183169: Pulse 2.0, Pulse Pro 2.0, NormaTec Industries, LP (2018) Summary page 4.

## Most influential descendants
- K240122: Normatec Elite (2024), 3 descendants of its own
- K221666: Normatec Go (2022), 2 descendants of its own
- K260529: Air Compression Massager (HY-1165) (2026), 0 descendants of its own
- 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

## Indications for use
The Normatec 3 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/K220217
Methodology: https://510kreport.com/methodology