Fd Tens 2050 or Slide Tens Model FD2050

by Fuji Dynamics, Ltd. 510(k)

Active United States

510(k) K111645

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK111645	Date9 Nov 2011Cleared	StatusActive

Coverage

1 jurisdiction

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Withdrawn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: K111645
FDA Product Code: GZJ
FDA applicant: Fuji Dynamics , Ltd.

Device Class: Class II
Regulation: 21 CFR Part 882.5890
Advisory Committee: Neurology
FDA Decision: SESE Substantially Equivalent

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