# K120783: ABLE-X

- Pathway: 510(k) (Traditional)
- Applicant: Im-Able, Ltd.
- Decided: Jun 20, 2012 after 97 days
- Product code: ION (Exerciser, Non-Measuring)
- Device class: 1
- Regulation: 21 CFR 890.5370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Encore Path's BatRac (Tail Wind): named in the summary without a submission number
- (no number) Accelerated Care Plus (ACP) Corporation's OmniVR Virtual Reality Rehabilitation System: named in the summary without a submission number

## Indications for use
The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: " Stroke rehabilitation by muscle re-education * Maintaining or increasing range of motion

Source page: https://510kreport.com/device/K120783
Methodology: https://510kreport.com/methodology