Data / Medical devices / Legging, Compression, Non-Inflatable
Legging, Compression, Non-Inflatable (LLK): 7 FDA-registered makers in 4 countries
7 establishments in 4 countries are registered with the FDA to make Legging, Compression, Non-Inflatable (product code LLK, Class 2, 21 CFR 880.5780). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 4 510(k) clearances under this code, the latest on November 2, 1990, and lists 1 recall event (1 Class I). FDA data exported November 2, 2026.
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- Product code
- LLK
- Device class
- 2
- Regulation
- 880.5780
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 4 |
| Mexico | 1 |
| China | 1 |
| Italy | 1 |
Makers of Legging, Compression, Non-Inflatable
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Aci Medical, LLC | San Marcos, CA, United States | Manufacturer | 1 | November 2, 1990 | 0 | 0 | 0 | api.fda.gov |
| DJ Orthopedics De Mexico, S.A. De C.V. | TIJUANA Baja California, Mexico | Manufacturer, Repackager or relabeler | 1 | December 11, 1987 | 0 | 0 | 0 | api.fda.gov |
| Djo, LLC | Carlsbad, CA, United States | Specification developer | 1 | December 11, 1987 | 0 | 0 | 0 | api.fda.gov |
| Gce International Inc | New York, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jinhua Beili Knitting Co.,ltd. | JINHUA Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Manifattura Ci-Zeta SRL | Passirano Brescia, Italy | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| STS Corporation | Duluth, GA, United States | Complaint file establishment, Repackager or relabeler, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 1990. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.