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)

B&J DVT Foot Garments, Models 820 Series

K-Number: K201547 · 2020-09-18

Decision Date2020-09-18
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

B&J DVT Foot Garments, Models 820 Series is the device name listed in this FDA 510(k) record. The listed applicant is B&J Manufacturing , Ltd.. It received FDA 510(k) clearance on 2020-09-18 under 510(k) number K201547. 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 B&J DVT Foot Garments, Models 820 Series?

B&J DVT Foot Garments, Models 820 Series is a medical device that received FDA 510(k) clearance on 2020-09-18. The listed applicant is B&J Manufacturing , Ltd.. The 510(k) number is K201547.

When did B&J DVT Foot Garments, Models 820 Series receive FDA 510(k) clearance?

B&J DVT Foot Garments, Models 820 Series received FDA 510(k) clearance on 2020-09-18, under 510(k) number K201547.

Who is the listed applicant for B&J DVT Foot Garments, Models 820 Series?

The FDA 510(k) record lists B&J Manufacturing , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for B&J DVT Foot Garments, Models 820 Series?

The FDA product code for B&J DVT Foot Garments, Models 820 Series is JOW.

Other records listing B&J Manufacturing , Ltd. 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.

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.

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.