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

THERATOUCH 4.7

K Number: K932868 · Decision Jul 29, 1994
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
43
Review Days
410

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Basic Information

Device Name
THERATOUCH 4.7
K Number
K932868
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Rich-Mar Corp.
Date Received
June 14, 1993
Decision Date
July 29, 1994
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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K013770 MODIFICATION TO: WINNER ST-2 STIMULATOR
K013771 MODIFICATION TO: WINNER CM-2 MUSCLE STIMULATOR, TENS, THERAPEUTIC ULTRASOUND AND COMBINATION DEVICE
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K000808 RICH-MAR WINNER ST4 MUSCLE STIMULATOR, INTERFERENTIAL, AND TENS DEVICE
K982544 RICH-MAR US500, US750, US1000 THERAPEUTIC UNLTRASOUND DEVICES
K952089 RICH-MAR CM-II COMBINED MUSCLE STIMULATOR, INTERFERENTIAL, TENS & THERAPEUTIC ULTRASOUND DEVICE
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