Product Code: ILG FDA class 1 21 CFR 890.3475

Stocking, Elastic

Physical Medicine

An Elastic Stocking is a compression garment used in Physical Medicine to apply graduated external pressure to the lower limb, used for the management of venous insufficiency, edema, lymphedema, and prevention of deep vein thrombosis. 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 ILG, regulated under 21 CFR 890.3475, within the Physical Medicine medical specialty. This device is GMP exempt, indicating it is not subject to full good manufacturing practice requirements.

510(k)s
8
FEI Numbers
101
Registration Numbers
101
Unique Applicants
8
Years Active
7

Research product code ILG in seconds

The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

Free to try · every answer cites its records

Basic Information

Product Code
ILG
Device Class
FDA class 1
Regulation Number
890.3475
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

Loading...

Related 510(k) Clearances

This FDA classification is associated with 8 510(k) clearances via K numbers.

K Number Device Name
K833437 ORTHOPEDIC STOCKINETTE
K831540 COMPRESSOGRIP ELASTIC STUMP SHRINKER#
K780612 STOCKINETTE, STERILE
K780547 STERILE ORTHOPEDIC STOCKINETTE
K770346 ORTHOPEDIC STOCKINETTE
K770173 STOCKINETTE
K760817 ORTHOPEDIC TUBULAR STOCKINETTE
K760576 TOURNIWRAP BANDAGE

FEI Numbers

This FDA classification entry is associated with 101 FEI numbers. Click on an entry to view related FDA registrations.

Registration Numbers

This FDA classification entry is associated with 101 registration numbers. Click on an entry to view related FDA registrations.