StressEraser FDA Registration

U.S. Food & Drug Administration Department of Health & Human Services

Centers for Devices & Radiological Health

Biofeedback devices, including the StressEraser are Class II devices. Most biofeedback devices require 510(k) approval. The StressEraser is one of a small group that is 510(k) exempt. The StressEraser is 510(k) exempt because it is battery-powered, and has no known long-term side effects or contraindications.

The indicated use of the StressEraser is for relaxation, relaxation training and stress reduction. The StressEraser’s stress reduction indication keeps the health risks low. The FDA’s Division of General, Neurological, and Restorative Devices (DGNRD) evaluates biofeedback devices. For the official definition of 510(k) exempt, please visit the FDA website.

Device Listing Database

Proprietary Name: STRESSERASER
Classification Name: DEVICE, BIOFEEDBACK
Product Code: HCC
Premarket Submission Number: Exempt
Listing Number: E408364
Device Class: 2
Regulation Number: 882.5050
Medical Specialty: Neurology

Facility

Registration Number: 3005357367
FEI Number: 3005357367
Registration Status: Active
Registration Status Reason: Registration number assigned
Initial Importer: Y
Facility Name:
WESTERN CAPE DIRECT, LLC
6079 PASEO CARRETA
CARLSBAD, CA 92009, UNITED STATES

Owner Operator

Owner Operator Number:  9077421
Owner Operator Business Name:
WESTERN CAPE DIRECT, LLC
Owner Operator Address:
6079 PASEO CARRETA
CARLSBAD, CA 92009, UNITED STATES