Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Radial Medical Compression System

K-Number: K181651 · 2018-10-12

ApplicantRadial Medical, Inc.
Decision Date2018-10-12
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Radial Medical Compression System is the device name listed in this FDA 510(k) record. The listed applicant is Radial Medical, Inc.. It received FDA 510(k) clearance on 2018-10-12 under 510(k) number K181651. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Radial Medical Compression System?

Radial Medical Compression System is a medical device that received FDA 510(k) clearance on 2018-10-12. The listed applicant is Radial Medical, Inc.. The 510(k) number is K181651.

When did Radial Medical Compression System receive FDA 510(k) clearance?

Radial Medical Compression System received FDA 510(k) clearance on 2018-10-12, under 510(k) number K181651.

Who is the listed applicant for Radial Medical Compression System?

The FDA 510(k) record lists Radial Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Radial Medical Compression System?

The FDA product code for Radial Medical Compression System is JOW.

Other records listing Radial Medical, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190976Radial Medical Compression System

Related Devices (Code: JOW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.K250974Bio Arterial Deluxe (IC-BAP-DX)Bio Compression Systems, Inc.K250190Sequential Compression System (SCD600)Shenzhen Comen Medical Instruments Co.,Ltd

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑