FDA classification code LLK describes a non-inflatable compression legging under the medical support stocking regulation and lists it as Class II with a 510(k) exemption. The entry is specific to that category; compare an exact garment's label and regulatory record before describing its status.
Compression products can be garments, inflatable systems or other devices with different intended uses. Their labels and FDA records should not be treated as interchangeable. This checklist covers product descriptions and regulatory status only.
Start with the exact garment
| Item | What to record |
|---|---|
| Product | Full model name and garment type |
| Manufacturer | Company name shown on the label or official product page |
| Construction | Inflatable or non-inflatable, and the body area named by the maker |
| Label | Stated compression range, materials, sizing and intended use |
| FDA details | Classification, product code, regulation number and any submission number |
The FDA classification for product code LLK describes a non-inflatable compression legging under regulation 880.5780. Its current entry lists Class II and a 510(k) exemption. That is one classification entry, not a blanket statement about compression socks, inflatable boots or every garment carrying a compression label.
Verify the regulatory record
- Copy the product name, manufacturer and any regulatory number from the exact model page or manual.
- Search the FDA device database using the name, company or product code.
- Compare the record’s classification and intended use with the garment description.
- Check whether the record is for the garment itself, another model or the manufacturing establishment.
- Use the status term shown in the FDA record. Do not infer a clearance from a registration or listing.
FDA explains that some Class II device types are exempt from 510(k) premarket notification. An exemption is a pathway detail for that classification; it does not automatically provide a clearance statement for every product in the category.
For pneumatic compression products, compare the compression boots product guide. For other device classifications, read our TENS status guide. For health questions or decisions about a garment, speak with a doctor.
Browse compression products.
Sources
Common questions
Does every compression garment have the same FDA status?
No. FDA classifications and product records depend on the specific device type and intended use. A category entry for a non-inflatable compression legging does not describe every garment.
What does FDA code LLK describe?
The FDA product classification page describes LLK as a non-inflatable compression legging under the medical support stocking regulation. It lists the device as Class II and 510(k) exempt.
Does 510(k) exempt mean FDA approved?
It means the classification entry lists that device type as exempt from premarket notification. It is not the same as an FDA approval or a product-specific clearance.
Does FDA registration prove a garment is cleared?
No. FDA says establishment registration and device listing do not by themselves denote approval, clearance or authorization.