# K183328: Pulse Rx 2.0, Pulse Pro Rx 2.0

- Pathway: 510(k) (Traditional)
- Applicant: NormaTec Industries, LP
- Decided: Dec 21, 2018 after 21 days
- Product code: JOW (Sleeve, Limb, Compressible)
- Device class: 2
- Regulation: 21 CFR 870.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K810338 (1981). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161346: NormaTec PCD-T and PCD-B, NormaTec Industries, LP (2016) Summary page 4.

## Indications for use
The NormaTec Pulse Rx 2.0 and Pulse Pro Rx 2.0 are intended to apply pressure to the extremities to treat: lymphedema and other edematous conditions, including congenital lymphedema (Millroy's disease, lymphedema praecox, and lymphedema tarda), post-mastectomy lymphedema, post-infection lymphedema, post-traumatic lymphedema, post-surgical lyphedema, post-radiation treatment lymphedema, venous insufficiency, venous stasis ulceration, and to prevent Deep Vein Thrombosis.

Source page: https://510kreport.com/device/K183328
Methodology: https://510kreport.com/methodology