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

FDA 510(k)

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

K-Number: K190423 · 2019-03-19

ApplicantDevon Medical Products (Jiangsu), Ltd.
Decision Date2019-03-19
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System is a medical device manufactured by Devon Medical Products (Jiangsu), Ltd.. It received FDA 510(k) clearance on 2019-03-19 under approval number K190423. 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 Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System?

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System is a medical device that received FDA 510(k) clearance on 2019-03-19. It is manufactured by Devon Medical Products (Jiangsu), Ltd.. The 510(k) number is K190423.

When was Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System approved by the FDA?

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System received FDA 510(k) clearance on 2019-03-19, under approval number K190423.

What company makes Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System?

Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System is manufactured by Devon Medical Products (Jiangsu), Ltd..

What is the FDA product code for Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System?

The FDA product code for Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System is JOW.

Related Clinical Trials

NCT01143558 Searching for Persistence of Infection in Lyme Disease COMPLETED NCT06727942 Virtual Reality-Infused Treadmill Training on Aging-Related Outcomes RECRUITING NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05016219 Phase 2 - Rhythmic Light Therapy for Alzheimer's Disease Patients RECRUITING NCT05003843 BOLT: Study of the Indigo® Aspiration System When Used in Patients With Deep Vein Thrombosis ACTIVE_NOT_RECRUITING NCT03280862 DANISH-CRT - Does Electric Targeted LV Lead Positioning Improve Outcome in Patients With Heart Failure and Prolonged QRS COMPLETED

Related PubMed Literature

PMID: 35685299 Multicenter, Double-Blinded, Randomized, Active-Sham Controlled Clinical Study Design to Assess the Safety and Effectiveness of a Novel High Frequency Electric Nerve Block System in the Treatment of Post-Amputation Pain (The QUEST Study). Journal of pain research (2022) PMID: 35047938 Evolution of the Vagus Nerve Stimulation (VNS) Therapy System Technology for Drug-Resistant Epilepsy. Frontiers in medical technology (2021) PMID: 29653650 Comparison of adverse event and device problem rates for transcatheter aortic valve replacement and Mitraclip procedures as reported by the Transcatheter Valve Therapy Registry and the Food and Drug Administration postmarket surveillance data. American heart journal (2018)

Other Devices by Devon Medical Products (Jiangsu), Ltd.

K172030Devon 51 K170814Devon 24 K182150Devon 52 Sequential Compression Device K173528Devon 24R Deep Vein Thrombosis (DVT) Prevention Therapy System K182578Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

Related Devices (Code: JOW)

K163055Reprocessed Kendall SCD Express Foot CuffCovidien K160180Intermittent Pneumatic Compression systemDaesung Maref Co., Ltd. K161105Reprocessed Compression GarmentsCovidien K160431ActiveCare HomeMedical Compression Systems (Dbn) , Ltd. K161346NormaTec PCD-T and PCD-BNormaTec Industries, LP K161209Cirona 6400Devon Medical Products

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.

↑