FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE


definition

Device Classification Name

stimulator, muscle, powered

510(k) Number K002410
Device Name FREED BIOELECTRIC: DYSPHAGIA TREATMENT DEVICE
Original Applicant
DYSPHAGIA, L.L.C.
3011 kersdale rd.
cleveland, 
OH 
44124

Original Contact marcy freed
Regulation Number 890.5850
Classification Product Code
IPF  
Date Received 08/07/2000
Decision Date 06/06/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

Neurology

Type Traditional
Reviewed by Third Party No

Combination Product

No