FDA 510(k) clearance · back to tracker

Bowhead ERA Wheelchairs

Bowhead Design Corp. cleared K243111 on 2025-01-10, decision: substantially equivalent

K-number

K243111

Sponsor

Bowhead Design Corp.

Device

Bowhead ERA Wheelchairs

Class

Class I

Decision

Substantially Equivalent

Decision date

2025-01-10

Product code

IOR

Advisory committee

Physical Medicine

Medical specialty

Physical Medicine

Regulation number

890.3850

Official FDA record

Open K243111on 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 K243111 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.