FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000

K Number: K033358 · Decision Nov 14, 2003
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
2
Review Days
25

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Basic Information

Device Name
CHRONIC PAIN SUPPRESSOR CPS-2000, MODEL CPS-2000
K Number
K033358
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Surgitech, Inc.
Date Received
October 20, 2003
Decision Date
November 14, 2003
Product Code
LIH
Advisory Committee
Neurology
Review Advisory Committee
NE
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
LIH Interferential Current Therapy

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K Number Device Name
K031576 SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1