FDA 510(k) FDA class 2 Substantially Equivalent 🇨🇦 Canada

ELECTROSTIM I.F.

K Number: K873566 · Decision Feb 1, 1988
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
3
Review Days
152

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Basic Information

Device Name
ELECTROSTIM I.F.
K Number
K873566
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Applicant
Promatek Industries, Ltd.
Date Received
September 2, 1987
Decision Date
February 1, 1988
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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Other Clearances by Promatek Industries, Ltd.

K Number Device Name
K901417 ELECTROSTIM MST
K871472 KINESTIM MUSCLE STIMULATOR