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GEN_2 Mechanical Wheelchair

by Free Wheelchair Mission 510(k)

Active United States

510(k) K113713

Overview

Discover the GEN_2 Mechanical Wheelchair, a high-quality device designed to provide independence and mobility for individuals with physical disabilities. Our wheelchair meets strict regulatory standards, ensuring safety, comfort, and accessibility. Learn more about its features, benefits, and compliance status.

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK113713 Date7 May 2012ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
IOR
Device Class
Class I
Regulation
21 CFR Part 890.3850
Advisory Committee
Physical Medicine
FDA Decision
SESE Substantially Equivalent

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