PROSTIM 1000/2000


Device Classification Name

stimulator, nerve, transcutaneous, for pain relief

510(k) Number K073438
Device Name PROSTIM 1000/2000
Applicant
BIO PROTECH, INC.
1676 village green suite a
crofton, 
MD 
21114

Applicant Contact e.j. smith
Regulation Number 882.5890
Classification Product Code
GZJ  
Date Received 12/07/2007
Decision Date 02/07/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No