FDA 510(k) clearance · back to tracker

IERO Mobility Scooter (IERO-01)

Jochu Technology Co., Ltd. cleared K261232 on 2026-07-14, decision: substantially equivalent

K-number

K261232

Sponsor

Jochu Technology Co., Ltd.

Device

IERO Mobility Scooter (IERO-01)

Class

Class II

Decision

Substantially Equivalent

Decision date

2026-07-14

Product code

INI

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3800

Official FDA record

Open K261232on 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 K261232 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.

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Source

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