FDA

Product Classification

Device

Stimulator, Cranial Electrotherapy

Regulation Description

Cranial Electrotheraphy Stimulator.

Regulation Medical Specialty

Neurology

Review Panel

Neurology

Product Code

JXK

Submission Type

510(k)

Regulation Number

882.5800

Device Class

3

GMP Exempt?

No

Third Party Review

Not Third Party Eligible