Antense Anti-Tension Device

FDA 510(k) K834110 · Bio Sig Instruments, Inc.

Substantially Equivalent

510(k) numberK834110

Submission

Device name
Antense Anti-Tension Device
Applicant
Bio Sig Instruments, Inc.
Mchenry, IL, US
Received
November 29, 1983
Decision date
February 4, 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

More from Medotech A/S

510(k)DeviceDecision
K834111Antache Anti-Headache DeviceHCC · Traditional 02/03/1984SE
K781387Insta-Pulse Heart Rate MonitorDRT · Traditional 09/20/1978SE

Questions and answers

When was Antense Anti-Tension Device cleared by the FDA?

Antense Anti-Tension Device (K834110) received a 510(k) decision of Substantially Equivalent on February 4, 1984, 67 days after the submission was received.

What is the product code of K834110?

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