Fd Tens 2090, Fd Tens 2095

by Fuji Dynamics, Ltd. 510(k)

Active United States

510(k) K152676

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK152676	Date22 Jan 2016Cleared	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Withdrawn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: K152676
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

Other devices from Fuji Dynamics Limited

Fuji Dynamics Incontinence Stimulation Electrode, Models Fuji – 01/ 02/ 03/ 04/ 05/ 06/ 07/ 08/ 09/ 10/ 11/ 12/ 13/ 14/ 15

Class II
Fdtens 2010

Class II
Fd Tens 2030, Model DFJ24T

Class II
Fd Tens 2070

Class II
Inf 4160, Model D-FJ27F

Class II
L-Tens

Class II

See all devices from Fuji Dynamics Limited →