FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR

K Number: K850877 · Decision Jun 12, 1985
Classifications
1
FEI Numbers
5
Registration Numbers
5
Same Product Code
35
Applicant Total
10
Review Days
103

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Basic Information

Device Name
MONOLIFT MPE2, PLATFORM, CHAIR, FULLY FUTO PLATFOR
K Number
K850877
Device Class
FDA class 2
Clearance Type
Traditional
Regulation Number
890.5150
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Ketronic, Inc.
Date Received
March 1, 1985
Decision Date
June 12, 1985
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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Other Clearances by Ketronic, Inc.

K Number Device Name
K850873 HILO TABLES, TYPE CH-4, CH-8, FW-6, FW-5, FW-2, AL
K850870 MEDIFETTE ERGOMETER
K850868 MFE CARDIAC STRESS SYSTEM
K850869 MFE COUCH ERGOMETER
K850872 PHYACTION 300, 360, 370, 390 & 391 ELEC-MUSCLE-STI
K850871 TREDBAND TYPE I, IT, II & III - TREADMILLS
K850876 LIGTVOET L80.2 LIGHTFOOT L80.2 POWER WHEELCHAIR
K850875 ACTION-WHEELS & PLAY WHEELS
K843288 KETRONIC MEDAX - N