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 more information, please see the CDRH website.
Device Listing Database
Proprietary Name: STRESSERASER
Classification Name: DEVICE, BIOFEEDBACK
Product Code: HCC
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
25 WASHINGTON ST., SUITE 526
BROOKLYN, NY 11201, UNITED STATES
Owner Operator
Owner Operator Number: 9077421
Owner Operator Business Name:
WESTERN CAPE DIRECT, LLC
Owner Operator Address:
25 WASHINGTON ST., SUITE 526
BROOKLYN, NY 11201, UNITED STATES
Owner Operator Phone Number: 718-596-4600
Owner Operator Fax Number: 212-346-9335
Official Correspondent
Owner Operator Business Name:
WESTERN CAPE DIRECT, LLC
Owner Operator Address:
25 WASHINGTON ST., SUITE 526
BROOKLYN, NY 11201, UNITED STATES
Owner Operator Phone Number: 718-596-4600
Owner Operator Fax Number: 212-346-9335
Registration Status
Expiration Date: 2009-12-31
PIN - PCN: 50013577 - 09116237