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510(k) K142236

Device
BioniCare Hand System
Applicant
VISION QUEST INDUSTRIES, INC.
510(k) number
K142236
Product code
NYN  
Decision
Substantially Equivalent (SESE)
Decision date
2015-03-23
Date received
2014-08-13
Regulation
882.5890
Classification name
Stimulator, Electrical, Transcutaneous, For Arthritis
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MOHAMED OUERGHI
Address
1390 Decision St., Suite A Vista CA US 92081 92081

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NYN  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K111557X-FORCESeven Seas Distribtion and Manufacturing, LLC2011-11-10
K073386JOINT STIM, MODEL 1000Pain Management Technologies2008-07-30
K062325RS-4I MUSCLE STIMULATOR FAMILYRs Medical2007-04-13
K052625BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000Bionicare Medical Technologies, Inc.2005-12-05
K030332MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000Bionicare Medical Technologies, Inc.2003-06-06
K983228BIONICARE STIMILATOR SYSTEM, MODEL BIO-1000Murray Electronics1999-03-15
K971437BIONICARE STIMULATOR SYSTEM. MODEL BIO-1000Murray Electronics1997-07-22

Legacy Summary#

summary

FDA Review#

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