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 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
Registered Establishment Name: HELICOR, INC.
Registered Establishment Number: 3005357367
Owner/Operator: HELICOR, INC.
Owner/Operator Number: 9077421
Establishment Operations: Repackager/Relabeler; Specification Developer

Establishment Registration Database

Establishment:

HELICOR, INC.
19 Fulton St., Suite 407
New York, NY 10038
Registration Number: 3005357367
Status: Active
Initial Distributor/Importer: Yes

*Note Firm may have additional establishment types.
Please review listings for further information.
Date of Registration Status: 2008

Owner/Operator:

HELICOR, INC.
19 Fulton St., Suite 407
New York, NY 10038
Owner/Operator Number: 9077421
Official Correspondent:
Kristin Gile
19 Fulton St., Suite 407
New York, NY 10038
Phone: 212-346-9339 x1009