Medisana Digital Tens

by Fuji Dynamics Limited 510(k)

Active United States

510(k) K994265

Regulatory status

as of 27 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK994265	Date6 Jul 2000Cleared	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Withdrawn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: K994265
FDA Product Code: GZJ

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

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