Stocking, Medical Support (For General Medical Purposes)
A medical support stocking for general medical purposes is a compression garment applied to the legs to improve venous circulation and reduce edema, commonly used in hospital and clinical settings. It is classified as FDA Class 1 (lowest risk), subject to general controls only, with no premarket notification required. The product code is FQL, regulated under 21 CFR 880.5780, within the General Hospital medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- FQL
- Device Class
- FDA class 1
- 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 6 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944240 | SOFT SOCK | Dec 27, 1994 | Substantially Equivalent | Silipos, Inc. |
| K823789 | ELASTIC COMPRESSION ANKLET | Jan 07, 1983 | Substantially Equivalent | Orthopaedic Resources Corp. |
| K823350 | ELASTIC COMPRESSION ANKLET | Dec 03, 1982 | Substantially Equivalent | Podiatry Products Corp. |
| K821260 | VITOFIT | Jun 23, 1982 | Substantially Equivalent | Selomas, Inc. |
| K821259 | VITASAN | Jun 23, 1982 | Substantially Equivalent | Selomas, Inc. |
| K820484 | VENES CUSTON RX | Mar 18, 1982 | Substantially Equivalent | Jung Products, Inc. |
FEI Numbers
This FDA classification entry is associated with 268 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 268 registration numbers. Click on an entry to view related FDA registrations.