FDA 510(k) clearance · back to tracker

Flexx Junior (FLX-J00, FLX-J50)

Karma Mobility Co, Ltd. cleared K250576 on 2025-11-04, decision: substantially equivalent

K-number

K250576

Sponsor

Karma Mobility Co, Ltd.

Device

Flexx Junior (FLX-J00, FLX-J50)

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-11-04

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K250576on 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 K250576 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.