ZeroPoint Compression — FDA Registered Class I Medical Device

ZeroPoint is the only brand that is FDA Registered as a Class I Medical Device as fully graduated, medical grade compression wear.

So what exactly does all of this mean?

The FDA, or the Food and Drug Administration, is U.S. governmental agency responsible for the safety of food, dietary supplements, drugs/medications, vaccines, blood products, cosmetics, and tobacco among other similar things. It is also responsible for medical devices.

Organizations/companies that manufacture products within the mentioned industries must register with the FDA. It’s important to note the difference between FDA registered and FDA approved. The FDA actually only “approves” drugs/medications and high-tech medical devices such as implantable defibrillators and similar devices and are considered in the FDA’s Class 3designation.

ZeroPoint Compression produces “medical grade” compression wear, available in two levels of compression: 15-20 mmHg and 20-30 mmHg.  What exactly do these levels represent?

Compression gear exerts a graduated amount of pressure as it goes towards the heart, and this unit of measure will indicated the amount of pressure the wearer will feel. Here’s a quick look at the different level of compression available:

8-15 mmHg: The lightest form of compression, and will generally be in socks to provide relieve from achy legs.

15-20 mmHg: This is considered “mild” compression and can give relief from minor to moderate swelling, aching, and varicose veins/ This level of compression is also effective in preventing deep vein thrombosis and/or blood clots (or economy class syndrome) while traveling, but they’re also good for anyone who stands or sits for long periods of time.

20-30 mmHg: This is the most commonly prescribed (medically) compression level and offers “moderate” pressure. This level of compression is great for relieving the symptoms of varicose veins, edema, deep vein thrombosis, and post-schlerotherapy. This level is also referred to as Class I or firm compression.

30-40 mmHg: Sometimes referred to as Class II compression, 30-40 mmHg compression gear can provide relief from severe edema, varicose veins, and deep vein thrombosis. They’re also prescribed for post-sclerotherapy and to heal active venous stasis ulcers. This level of compression should only be worn under a doctor’s supervision.

40-50 mmHg: This is the highest level of compression and should only be worn under the direction and prescribed  by a physician. This level is typically used to treat chronic venous insufficiency and post-thrombotic syndrome.

(Please note: The information provided here is for general reference only and is not meant to act as medical advice.)

ZeroPoint Compression Levels

As we previously stated, ZeroPoint produced compression products that are considered medical grade. We have products available in to levels of compression — 15-20 mmHg and 20-30 mmHG.

As with medical compression garments, the main benefit that compression gear for athletes is increases in blood circulation levels to provide benefits such as relieving aches and pains, faster muscles recovery and many others. Our compression gear can also help prevent injuries such as strains and sprains.

Please contact us at ZeroPoint Compression if you have any questions about our FDA status or just have general questions about our high-level compression gear.

0/5 (0 Reviews)