The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device. ComfortPress is designed to enhance comfort for the…
The ComfortPress Hand-Held Vascular Compression Assist Device is an ergonomic, sterile, disposable external compression device. ComfortPress is designed to enhance comfort for the practitioner and the patient when applying external compression of the femoral artery. Practitioners apply external pressure using ComfortPress in much the same way that they would when applying manual pressure. The Model 3100-03 is a large sterile molded handle fitted with a Large SuperComfort™ Disc in a sealed package. This is a single use device.
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 ComfortPress 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) | K072167 |
| Record published | 2016-09-24 |
| Record revised | 2024-10-16 (version 7) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 20 |
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.