BIOFLEX PROFESSIONAL THERAPY SYSTEM


Device Classification Name

lamp, infrared, therapeutic heating

510(k) Number K023621
Device Name BIOFLEX PROFESSIONAL THERAPY SYSTEM
Original Applicant
MEDITECH INTERNATIONAL, INC.
1151 hope st.
stamford, 
CT 
06907

Original Contact richard keen
Regulation Number 890.5500
Classification Product Code
ILY  
Date Received 10/29/2002
Decision Date 04/10/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Physical Medicine

510k Review Panel

General & Plastic Surgery

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No