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510(k) K030332

Device
MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000
Applicant
BIONICARE MEDICAL TECHNOLOGIES, INC.
510(k) number
K030332
Product code
NYN  
Decision
Substantially Equivalent (SESE)
Decision date
2003-06-06
Date received
2003-01-31
Regulation
882.5890
Classification name
Stimulator, Electrical, Transcutaneous, For Arthritis
Medical specialty
Neurology
Review panel
Neurology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
KENT HOFFMAN
Address
47 R Loveton Cir. Sparks MD US 21152 21152

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
K142236BioniCare Hand SystemVision Quest Industries, Inc.2015-03-23
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
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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