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NYN — Stimulator, Electrical, Transcutaneous, For Arthritis Class II

FDA Device Classification

Classification Details

Product Code
NYN
Device Class
Class II
Regulation Number
882.5890
Submission Type
Review Panel
NE
Medical Specialty
Neurology
Implant
No

Definition

Electrical stimulation unit with leads and cutaneous electrodes used to apply an electrical current through electrodes on patient's skin to provide relief of pain associated with arthritis (including osteoarthritis and rheumatoid arthritis).

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K142236vision quest industriesBioniCare Hand SystemMarch 23, 2015
K111557seven seas distribtion and manufacturingX-FORCENovember 10, 2011
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K062325rs medicalRS-4I MUSCLE STIMULATOR FAMILYApril 13, 2007
K052625bionicare medical technologiesBIONICARE STIMULATOR SYSTEM, MODEL BIO-1000December 5, 2005
K030332bionicare medical technologiesMODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000June 6, 2003
K983228murray electronicsBIONICARE STIMILATOR SYSTEM, MODEL BIO-1000March 15, 1999
K971437murray electronicsBIONICARE STIMULATOR SYSTEM. MODEL BIO-1000July 22, 1997