Calmare Therapeutics Inc (fka CTTC)

[andy55q]

Device Classification Name Stimulator, Nerve, Transcutaneous, For Pain Relief
510(K) Number K081255
Device Name SCRAMBLER ST 5 TENS DEVICE
Applicant
COMPETITIVE TECHNOLOGIES,INC.
49 Plain St.
North Attleboro, MA 02760 -2
Applicant Contact Mary Mcnamara
Correspondent
COMPETITIVE TECHNOLOGIES,INC.
49 Plain St.
North Attleboro, MA 02760 -2
Correspodent Contact Mary Mcnamara
Regulation Number 882.5890
Classification Product Code
GZJ
Date Received 05/02/2008
Decision Date 02/20/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Neurology
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed By Third Party No
Combination Product No

http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K081255