KNEEHAB XP


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K110350
Device Name KNEEHAB XP
Applicant
BIO-MEDICAL RESEARCH, LTD.
parkmore business park, west
galway, 

IE

ei

Applicant Contact anne-marie keenan
Correspondent
BIO-MEDICAL RESEARCH, LTD.
parkmore business park, west
galway, 

IE

ei

Correspodent Contact anne-marie keenan
Regulation Number 882.5890
Classification Product Code
GZJ  
Subsequent Product Codes
IPF   NYN  
Date Received 02/07/2011
Decision Date 08/03/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No