FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

SPINAL TOUCH

K Number: K961212 · Decision Jun 12, 1996
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
32
Applicant Total
9
Review Days
76

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Basic Information

Device Name
SPINAL TOUCH
K Number
K961212
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
888.1500
Medical Specialty
Orthopedic
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Fasstech
Date Received
March 28, 1996
Decision Date
June 12, 1996
Product Code
KQX
Advisory Committee
Orthopedic
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
KQX Goniometer, Ac-Powered

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K Number Device Name
K063447 INSIGHT DISCOVERY
K033452 CWAS 1000
K023209 INSIGHT MILLENNIUM III
K011964 INSIGHT MILLENNIUM PLUS
K011983 INSIGHT GENESIS
K990778 INSIGHT MILLENNIUM
K940050 FOCUS EMG
K925197 PSI 220 DUAL EMG