# K183169: Pulse 2.0, Pulse Pro 2.0

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Dec 27, 2018 after 41 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: 7 generations back to K850316 (1985). 18 ancestors in all.
10 later devices descend from it; 3 cite it directly.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160608: NormaTec Pulse and NormaTec Pulse Pro, NormaTec Industries, LP (2016) Summary page 4.

## Most influential descendants
- K220217: Normatec 3 (2022), 7 descendants of its own
- 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

## Indications for use
The NormaTec Pulse 2.0 and Pulse Pro 2.0 are air pressure massagers 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/K183169
Methodology: https://510kreport.com/methodology