FDA 510(k) FDA class 2 Substantially Equivalent 🇹🇼 Taiwan

IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND

K Number: K024100 · Decision Feb 25, 2003
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
72
Applicant Total
5
Review Days
75

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Basic Information

Device Name
IF SERIES TRUE SINE INTERFERENTIAL STIMULATOR/MODEL: WL-2206, WELL IF, LIFE IF AND THE CUSTOMER PRIVATE BRAND
K Number
K024100
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
882.5890
Medical Specialty
Neurology
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Theratech, Inc.
Date Received
December 12, 2002
Decision Date
February 25, 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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Other Clearances by Theratech, Inc.

K Number Device Name
K060975 IF TRUE SINE INTERFERENTIAL STIMULATOR / MODEL WL-2206A1 & WI-2206A2
K050847 IF TRUE SINE INTERFERENTIAL STIMULATOR, MODEL WL-2206A
K021436 TTECH MODEL 200E + TENS DEVICE
K013768 POWERED MUSCLE STIMULATOR