FDA applicant
Im-Able, Ltd.
FDA records 1 decision for Im-Able, Ltd. (Palos Verdes Estates, CA) in 2012: 1 510(k) clearance. All are in product code ION (Exerciser, Non-Measuring). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Im-Able, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2012
2012high 1 (2012) · low 0 (2013)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2012.
Planning a device like Im-Able, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report