Device

device, biofeedback

Regulation Description

Biofeedback device.

Regulation Medical Specialty

Neurology

Review Panel

Neurology

Product Code

HCC

Submission Type

510(k) Exempt

Regulation Number

882.5050

Device Class

2

GMP Exempt?

No

    Note: Class II Devices The Food and Drug Administration (FDA) has also published a list of class II (special controls) devices subject to certain limitations, that are now exempt from the premarket notification requirements under the Food and Drug Administration Modernization Act of 1997 (the Modernization Act). FDA believes that these exemptions will relieve manufacturers from the need to submit premarket notification submissions for these devices and will enable FDA to redirect the resources that would be spent on reviewing such submissions to more significant public health issues. FDA is taking this action in order to meet a requirement of the Modernization Act.

Third Party Review

Not Third Party Eligible

Proprietary Device Name:

E.P.F.X.

Common/Generic Device Name:

BIOFEEDBACK

Classification Name:

DEVICE, BIOFEEDBACK

Device Class:

2

Product Code:

HCC

Regulation Number:

882.5050

Medical Specialty:

Neurology

Owner/Operator:

ECLOSION KFT.

Owner/Operator Number:

9061821

Registered Establishment Name:

ECLOSION KFT.

Establishment Registration Number:

3004444071

Date of Listing:

04/11/05

Listing Status:

Active

Establishment Operations:

Manufacturer