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

QUALINE WHEELCHAIR PRODUCTS

K Number: K843213 · Decision Aug 24, 1984
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
23
Applicant Total
1
Review Days
9

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Basic Information

Device Name
QUALINE WHEELCHAIR PRODUCTS
K Number
K843213
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.3880
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Contemporary Health Sys
Date Received
August 15, 1984
Decision Date
August 24, 1984
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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