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

BRUNO ELECTRA-RIDE, MODEL SRE-2700

K Number: K022509 · Decision Aug 13, 2002
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
35
Applicant Total
12
Review Days
14

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Basic Information

Device Name
BRUNO ELECTRA-RIDE, MODEL SRE-2700
K Number
K022509
Device Class
FDA class 2
Clearance Type
Special
Regulation Number
890.5150
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Statement or Summary
Statement
Applicant
Bruno Independent Living Aids, Inc.
Date Received
July 30, 2002
Decision Date
August 13, 2002
Product Code
ILK
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
ILK Transport, Patient, Powered

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K033829 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100
K033752 BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540
K033438 BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000
K011227 REGAL MOTOTRIZED 3 WHEELED VEHICLE
K002205 CARONY
K991954 THE BRUNO POWERBASE, MODEL PSB-2200
K970927 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM
K921647 REGAL MOTORIZIED 3 WHEELED VEHICLE
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