X-FORCE


Device Classification Name

stimulator, electrical, transcutaneous, for arthritis

510(k) Number K111557
Device Name X-FORCE
Applicant
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
2620 s maryland pkwy
ste 14 unit 835
las vegas, 
NV 
89109

Applicant Contact mark ioele
Correspondent
SEVEN SEAS DISTRIBTION AND MANUFACTURING LLC
2620 s maryland pkwy
ste 14 unit 835
las vegas, 
NV 
89109

Correspodent Contact mark ioele
Regulation Number 882.5890
Classification Product Code
NYN  
Date Received 06/03/2011
Decision Date 11/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No