# K220213: Empulse R90

- Pathway: 510(k) (Traditional)
- Applicant: Sunrise Medical (Us), LLC
- Decided: Mar 30, 2022 after 63 days
- Product code: ITI (Wheelchair, Powered)
- Device class: 2
- Regulation: 21 CFR 890.3860
- 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 K001491 (2000). 4 ancestors in all.
No later device cites it as a predicate yet.
1 of 5 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151199: SmartDrive Wheelchair Power Assist, Max Mobility, LLC (2015) Summary page 4.
- K140204: JWX-2, Yamaha Motor Co., Ltd. (2014) Summary page 4.

## Indications for use
The Empulse R90 is intended to be used to provide power assistance to manual wheelchair users. It is designed to augment the manual propulsion provided by the user, reducing the effort required by the user to propel the wheelchair.

Source page: https://510kreport.com/device/K220213
Methodology: https://510kreport.com/methodology