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

ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON

K Number: K890143 · Decision May 1, 1989
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
8
Applicant Total
4
Review Days
108

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Basic Information

Device Name
ACUTRON MULTIWAVE FOR USE IN TMJ SYNDROME PAIN CON
K Number
K890143
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5850
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Microcurrent Research, Inc.
Date Received
January 13, 1989
Decision Date
May 1, 1989
Product Code
NUW
Advisory Committee
Physical Medicine
Review Advisory Committee
DE
Third Party
N

Classifications

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

Product Code Device Name
NUW Stimulator, Muscle, Powered, Dental

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Other Clearances by Microcurrent Research, Inc.

K Number Device Name
K981976 ACUTRON MENTOR MODEL 961
K901902 ACUSOURCE 600 FOR USE WITH TMJ ELECTRODE
K895977 ACUSOURCE 600 (TENS)