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FDA 510(k)

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device

K-Number: K182578 · 2019-02-21

ApplicantDevon Medical Products (Jiangsu), Ltd.
Decision Date2019-02-21
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a medical device manufactured by Devon Medical Products (Jiangsu), Ltd.. It received FDA 510(k) clearance on 2019-02-21 under approval number K182578. 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 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device?

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is a medical device that received FDA 510(k) clearance on 2019-02-21. It is manufactured by Devon Medical Products (Jiangsu), Ltd.. The 510(k) number is K182578.

When was Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device approved by the FDA?

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device received FDA 510(k) clearance on 2019-02-21, under approval number K182578.

What company makes Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device?

Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is manufactured by Devon Medical Products (Jiangsu), Ltd..

What is the FDA product code for Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device?

The FDA product code for Devon 62 Deep Vein Thrombosis (DVT) Prevention Therapy Device is JOW.

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Related PubMed Literature

PMID: 41105489 Medical device shelf-life and recalls: navigating healthcare challenges. Expert review of medical devices (2025) PMID: 40833550 Navigating Medical Device Safety: Current Status, Challenges, and Future Regulatory Directions. Drug safety (2026) PMID: 39556835 Information Disclosure, Medical Device Regulation, and Device Safety: The Case of Cook Celect IVC Filters. Annals of internal medicine (2024) PMID: 35985696 Regulatory reliance for convergence and harmonisation in the medical device space in Asia-Pacific. BMJ global health (2022)

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 K190423Devon 24D Deep Vein Thrombosis (DVT) Prevention Therapy System

Related Devices (Code: JOW)

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Official Source

View on FDA Database →

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