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

CALIFORNIA COMFORT FOUR WHEEL

K Number: K895384 · Decision Sep 18, 1989
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
23
Applicant Total
1
Review Days
19

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Basic Information

Device Name
CALIFORNIA COMFORT FOUR WHEEL
K Number
K895384
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.3880
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Jubilee Scooters, Inc.
Date Received
August 30, 1989
Decision Date
September 18, 1989
Product Code
IQC
Advisory Committee
Physical Medicine
Review Advisory Committee
PM
Third Party
N

Classifications

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

Product Code Device Name
IQC Wheelchair, Special Grade

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