The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external…
The CompressAR Compass Hand-Held Compression Assist Device is a hand-held external compression device designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using Compass in much the same way that they would when applying manual pressure. The CompressAR Compass Hand-Held Compression Assist Device is comprised of a non-sterile handle for use with disposable, sterile SuperComfort compression discs (Model 5303 or 5305).
Who Else Makes It
Concentrated in Beijing (3), Zhejiang (2), Guangdong (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for CompressAR Compass Hand-Held Vascular Compression Assist Device | Listed by | Semler Technologies, Inc., United States |
| FDA product code | DXC |
| Device type | Clamp, Vascular |
| Device class | Class 2 |
| Regulation | 21 CFR 870.4450 |
| 510(k) | K053398 |
| Record published | 2016-09-24 |
| Record revised | 2025-05-02 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date |
| Distribution end date | 2025-04-30 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.