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

WALK N CHAIR

K Number: K935211 · Decision Feb 2, 1994
Classifications
1
FEI Numbers
129
Registration Numbers
129
Same Product Code
458
Applicant Total
2
Review Days
96

Research this 510(k) in seconds

The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

Free to try · every answer cites its records

Basic Information

Device Name
WALK N CHAIR
K Number
K935211
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.3850
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Brookefield Hunter, Inc.
Date Received
October 29, 1993
Decision Date
February 2, 1994
Product Code
IOR
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
IOR Wheelchair, Mechanical

Similar 510(k) Clearances

Other 510(k) clearances with the same product code (IOR), ordered by most recent decision date.

View all

Other Clearances by Brookefield Hunter, Inc.

K Number Device Name
K915609 ULTRA R-11 CRUISER