Stress Control Biofeedback Card

FDA 510(k) K843413 · Pilgrim Plastic Products Co.

Substantially Equivalent

510(k) numberK843413

Submission

Device name
Stress Control Biofeedback Card
Applicant
Pilgrim Plastic Products Co.
Boston, MA, US
Received
August 31, 1984
Decision date
November 27, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
HCC – Device, Biofeedback
Device class
Class II (moderate risk)
Regulation
21 CFR 882.5050
Specialty
Neurology

Other 510(k)s with product code HCC

510(k)DeviceApplicantDecision
K233580A Breathing System (ABS)HCC · Traditional Deepwell Dtx, Inc.08/01/2024SE
K222101PrismHCC · Traditional Graymatters Health , Ltd.03/17/2023SE
K180173FreespiraHCC · Traditional Palo Alto Health Sciences, Inc.08/23/2018SE
K163448GrindCare SystemHCC · Traditional Sunstar Suisse S.A.09/01/2017SE
K151050Pacifier Activated Lullaby (PAL®)HCC · Traditional Power Medical Devices, LLC12/22/2015SE
K143507NFANT Feeding SolutionHCC · Traditional Nfant Labs, LLC09/09/2015SE
K131586Canary Breathing SystemHCC · Traditional Palo Alto Health Sciences, Inc.12/10/2013SE
K122879EEGER4 Model 4.3HCC · Traditional Eeg Software, LLC02/06/2013SE
K111687Emg SystemHCC · Special Myotronics-Noromed, Inc.09/29/2011SE
K092675GrindcareHCC · Traditional Medotech A/S03/03/2010SE

Questions and answers

When was Stress Control Biofeedback Card cleared by the FDA?

Stress Control Biofeedback Card (K843413) received a 510(k) decision of Substantially Equivalent on November 27, 1984, 88 days after the submission was received.

What is the product code of K843413?

The FDA product code is HCC – Device, Biofeedback, a Class II (moderate risk) device regulated under 21 CFR 882.5050.