Medical Device Manufacturer · US , Orinda , CA

Dyansys, Inc.

14 submissions · 14 cleared · Since 2007
14
Total
14
Cleared
0
Denied

Dyansys, Inc. — FDA 510(k) Submissions

Dyansys, Inc. has submitted 14 FDA 510(k) premarket notifications since 2007, of which 14 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrocardiograph, Stimulator, Nerve, Electrical, Percutaneous (pens), For Pain Relief, Percutaneous Nerve Stimulator For Opioid Withdrawal, Stimulator, Electro-acupuncture, Non-implanted Nerve Stimulator For Pain Associated With Irritable Bowel Syndrome (ibs) . Use the specialty filter in the sidebar to narrow results.

14 devices
1–14 of 14
Primary Relief
K221425 · NHI Stimulator, Nerve,... · Neurology
Sep 2022 120d
Drug Relief v1
K221231 · PZR Percutaneous Nerve... · Neurology
Jun 2022 38d
ANSiStim-PP
K220397 · NHI Stimulator, Nerve,... · Neurology
May 2022 90d
Primary Relief
K213188 · NHI Stimulator, Nerve,... · Neurology
Jan 2022 124d
First Relief
K212859 · NHI Stimulator, Nerve,... · Neurology
Dec 2021 103d
Drug Relief v1
K211971 · PZR Percutaneous Nerve... · Neurology
Nov 2021 134d
First Relief v1
K202940 · QHH Non-implanted Nerve... · Neurology
Dec 2020 90d
Drug Relief
K173861 · PZR Percutaneous Nerve... · Neurology
May 2018 133d
ANSiStim-PP
K170391 · BWK Stimulator,... · Neurology
Mar 2017 29d
ANSISTIM
K141168 · BWK Stimulator,... · Neurology
May 2015 374d
ECSCOPE 200
K091397 · DPS Electrocardiograph · Cardiovascular
Jul 2009 57d
ECSCOPE 100
K091358 · DPS Electrocardiograph · Cardiovascular
May 2009 20d
PORTABLE ECSCOPE 12I
K080036 · DPS Electrocardiograph · Cardiovascular
Jan 2008 9d
THE PORTABLE ANSISCOPE
K071168 · DPS Electrocardiograph · Cardiovascular
Aug 2007 126d
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