Ballancer 505 System, Model 1201-AC

by Mego Afek AC, Ltd. 510(k)

Active United States

510(k) K150269

Regulatory status

as of 26 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK150269	Date26 May 2015Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Specification

510(k)

510(k) Number: K150269
FDA Product Code: IRP
FDA applicant: Mego Afek AC , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 890.5650
Advisory Committee: Physical Medicine
FDA Decision: SESE Substantially Equivalent

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