Product Code: ILZ FDA class 1 21 CFR 890.5925

Accessories, Traction

Physical Medicine

Traction Accessories are supplementary components used with physical medicine traction devices, including harnesses, spreader bars, pulleys, and weights that form part of a mechanical traction system used to apply stretching forces to the spine or limbs for pain relief and musculoskeletal treatment. It is classified as FDA Class 1, the lowest risk category, subject only to general controls with no premarket submission required. The product code is ILZ, regulated under 21 CFR 890.5925, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: ILZ
Device Class: FDA class 1
Regulation Number: 890.5925
Medical Specialty: Physical Medicine
Review Panel: PM
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 15 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K921711	FLEXION DISTRATION SUPPORT	Jul 13, 1992	Substantially Equivalent	Altoona Medical Supply
K895382	VIBRA-TRAC TRACTION TABLE	Oct 16, 1989	Substantially Equivalent	Vibra-Trac Industries
K884340	AMX-110, AMX-II AND AMX-III	Jan 24, 1989	Substantially Equivalent	Dyna-Med
K852398	VECTOR BAR SUSPENSION/TRACTION UNIT	Aug 12, 1985	Substantially Equivalent	Powlan Manufacturing Co.
K844490	TRACTION ACCESSORIES	Feb 21, 1985	Substantially Equivalent	Jerome Medical
K831135	SAUNDERS #7080 CERVICAL TRACTION SYS	Jun 24, 1983	Substantially Equivalent	Chattanooga Group, Inc.
K830245	HEAD HALTER	Mar 09, 1983	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823659	PELVIC TRACTION BELT	Dec 30, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K823166	PELVIC TRACTION BELT	Nov 10, 1982	Substantially Equivalent	Warm & Form, Orthopedic Materials
K820663	BOGER AUTO-TRACTION DEVICE	May 03, 1982	Substantially Equivalent	D.C. Medical Device, Inc.
K791808	CERVI-TRAC	Oct 01, 1979	Substantially Equivalent	Dr. K.G. Rude
K780227	BANDAGE SPREADER BLOCK	Mar 15, 1978	Substantially Equivalent	Biomet, Inc.
K780234	TRACTION BELT, PELVIC	Feb 23, 1978	Substantially Equivalent	Biomet, Inc.
K780226	SPREADER BARS	Feb 17, 1978	Substantially Equivalent	Biomet, Inc.
K770607	TRACTION HARNESS	Apr 08, 1977	Substantially Equivalent	Will Ross Co.