Data / Medical devices / United States / Compression Solutions, LLC
Compression Solutions, LLC: FDA-registered device maker in Charlotte, NC, United States, 3 510(k) clearances
Compression Solutions, LLC is registered with the FDA (registration 3008902816) in Charlotte, NC, United States. It lists 4 device types. The FDA files 3 510(k) clearances under its listings, the newest dated June 12, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008902816
- Address
- 5825 Carnegie Blvd, Suite 300, Charlotte, NC, United States, 28209
- Owner or operator
- Compression Solutions, LLC (10035499)
- Roles
- Specification developer
- First device listed
- March 2, 2011
- Registered through
- 2026
- Brand names listed
- EZ-Fit VT - Compression Calf Sleeve - TP-3333, EZ-Fit VT - Compression Calf Sleeve - TP-3333VQ, EZ-Fit VT - Compression Calf Sleeve - TP-3333s, GP-AN-01 - Ankle Orthosis Reusable Gel Pack, GP-AN-01T - Ankle Orthosis Resuable Gel Pack (Tongue Accessory), GP-KN-01 - Knee Orthosis Reusable Cold Pack, GP-SH-01 - Shoulder Orthosis Reusable Cold Pack, ICE-04-01 - Reusable Ice Bag for Knee Orthosis and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Specification developer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Specification developer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| June 12, 2014 | K141360 | TRIPLEPLAY PRO | JOW | Substantially Equivalent | Wildcat Medical, Inc. | accessdata.fda.gov |
| November 21, 2012 | K122154 | POWERPLAY MUSCLE MASSAGER | IRP | Substantially Equivalent | Fig, LLC | accessdata.fda.gov |
| January 26, 2011 | K103187 | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM | JOW | Substantially Equivalent | Wildcat Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Orthosis, Limb Brace
- All makers of Massager, Powered Inflatable Tube
- All makers of Sleeve, Limb, Compressible
- All makers of Pack, Hot Or Cold, Reusable
Updated June 12, 2014. 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.