Stocking, Elastic
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.
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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
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 8 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833437 | ORTHOPEDIC STOCKINETTE | Nov 03, 1983 | Substantially Equivalent | Northern Medical Surgical, Inc. |
| K831540 | COMPRESSOGRIP ELASTIC STUMP SHRINKER# | Jun 08, 1983 | Substantially Equivalent | Fred Sammons, Inc. |
| K780612 | STOCKINETTE, STERILE | Apr 19, 1978 | Substantially Equivalent | Abco Dealers, Inc. |
| K780547 | STERILE ORTHOPEDIC STOCKINETTE | Apr 10, 1978 | Substantially Equivalent | Alba-Waldensian, Inc. |
| K770346 | ORTHOPEDIC STOCKINETTE | Mar 07, 1977 | Substantially Equivalent | Convertors |
| K770173 | STOCKINETTE | Feb 08, 1977 | Substantially Equivalent | Chase Mfg. Co. |
| K760817 | ORTHOPEDIC TUBULAR STOCKINETTE | Oct 20, 1976 | Substantially Equivalent | Parke-Davis Co. |
| K760576 | TOURNIWRAP BANDAGE | Oct 05, 1976 | Substantially Equivalent | Richard'S Medical Equip., Inc. |
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.