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

TRACTION ACCESSORIES

K Number: K844490 · Decision Feb 21, 1985
Classifications
1
FEI Numbers
41
Registration Numbers
41
Same Product Code
14
Applicant Total
9
Review Days
93

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Basic Information

Device Name
TRACTION ACCESSORIES
K Number
K844490
Device Class
FDA class 1
Clearance Type
Traditional
Regulation Number
890.5925
Medical Specialty
Physical Medicine
Decision
Substantially Equivalent
Applicant
Jerome Medical
Date Received
November 20, 1984
Decision Date
February 21, 1985
Product Code
ILZ
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
ILZ Accessories, Traction

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Other Clearances by Jerome Medical

K Number Device Name
K051918 RESOLVE OPEN BACK HALO RINGS
K930021 J TONGS
K930153 SYSTEM III HALO RING
K882877 JMS CERVICAL TRACTION DEVICE/HALO DEVICE
K870053 TORQUEDRIVER WRENCH
K864969 JMS HALO APPLICATION TRAY
K822780 CERVICAL BRACE
K821582 WARM'N FORM SPORTS SUPPORTS