Legging, Compression, Non-Inflatable
Legging, Compression, Non-Inflatable is a garment device that applies graduated external pressure to the lower limbs through elastic or fabric compression, used to manage chronic venous insufficiency, prevent deep vein thrombosis, reduce edema, and aid in post-surgical recovery. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LLK, regulated under 21 CFR 880.5780, within the General Hospital medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- LLK
- Device Class
- FDA class 2
- Regulation Number
- 880.5780
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K903532 | UNNA-SLEEVE(TM) | Nov 02, 1990 | Substantially Equivalent | Aci Medical, Inc. |
| K873368 | TECNOL COMPRESSION KNEE DRESSING | Dec 11, 1987 | Substantially Equivalent | Tecnol New Jersey Wound Care, Inc. |
| K871889 | COMPRESSION LEGGING DEVICE | Aug 04, 1987 | Substantially Equivalent | A-T Surgical Mfg. Co., Inc. |
| K834460 | MODEL 1888 ALPHA COS/RESPIRATION CAR | Feb 13, 1984 | Substantially Equivalent | Spacelabs, Inc. |
FEI Numbers
This FDA classification entry is associated with 8 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 8 registration numbers. Click on an entry to view related FDA registrations.