# K143197: Nice1

- Pathway: 510(k) (Traditional)
- Applicant: Nice Recovery Systems, LLC
- Decided: Dec 23, 2014 after 47 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: 2 generations back to K951769 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K071050: Game Ready Professional Therapy System, Model 550100, Game Ready Pre-Programmed Professional Therapy System, Coolsystems, Inc. (2007) Summary page 5.

## Most influential descendants
- K253150: Cryon-X Cold Compression (2025), 0 descendants of its own

## Indications for use
The Nice1 combines cold and compression therapies. It is intended to treat post-surgical and acute injuries to reduce edema, swelling, and pain where cold and compression are indicated. It is intended to be used by or on the order of a healthcare professional in hospital, outpatient clinics, athletic training settings, or home settings.

Source page: https://510kreport.com/device/K143197
Methodology: https://510kreport.com/methodology