FDA 510(k) clearance · back to tracker

ICON 35; ICON 45; ICON 60; ICON 30FAF

Rehasense USA, Inc. cleared K260849 on 2026-06-11, decision: substantially equivalent

K-number

K260849

Sponsor

Rehasense USA, Inc.

Device

ICON 35; ICON 45; ICON 60; ICON 30FAF

Class

Class I

Decision

Substantially Equivalent

Decision date

2026-06-11

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K260849on accessdata.fda.gov →

FDA's authoritative 510(k) summary page. Includes the decision letter, predicate references, and downloadable substantial-equivalence determination.

openFDA JSON

Raw record →

Machine-readable JSON. Useful for cross-referencing classification, product code, and advisory committee fields.

Use this as a predicate

Drop K260849 into Compass and start a substantial-equivalence draft.

Compass pulls the predicate's intended use, technological characteristics, and performance data, maps them against your device, and produces a draft SE table aligned to FDA's 510(k) program guidance.

Try the sandbox

Source

Public 510(k) database, U.S. Food and Drug Administration, accessed via openFDA. Page refreshed weekly.