FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM


Device Classification Name

stimulator, spinal-cord, implanted (pain relief)

510(k) Number K141399
Device Name FREEDOM SPINAL CORD STIMULATOR (SCS) SYSTEM
Applicant
STIMWAVE TECHNOLOGIES INCORPORATED
420 lincoln rd suite 365
miami beach, 
FL 
33139

Applicant Contact elizabeth greene
Correspondent
STIMWAVE TECHNOLOGIES INCORPORATED
420 lincoln rd suite 365
miami beach, 
FL 
33139

Correspodent Contact elizabeth greene
Regulation Number 882.5880
Classification Product Code
GZB  
Date Received 05/28/2014
Decision Date 10/10/2014
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Neurology

510k Review Panel

Neurology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No