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

COMMODE CHAIR 98200

K Number: K842651 · Decision Aug 7, 1984
Classifications
1
FEI Numbers
301
Registration Numbers
301
Same Product Code
30
Applicant Total
8
Review Days
28

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Basic Information

Device Name
COMMODE CHAIR 98200
K Number
K842651
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.5050
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Guardian Products Co., Inc.
Date Received
July 10, 1984
Decision Date
August 7, 1984
Product Code
ILS
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
ILS Adaptor, Hygiene

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Other Clearances by Guardian Products Co., Inc.

K Number Device Name
K915108 FOLDING WHEELCHAIR
K842650 WALL GRAB BARS 98130-98136
K842649 BATH TUB TRANSFER CHAIR
K821010 BATHTUB TRANSFER BENCH
K821009 BATHTUB GRAB BAR
K790299 FOREARM-CANE
K772049 WALKING AID