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)

Circul8 Pro

K-Number: K212731 · 2021-11-15

ApplicantOrtho8, Inc.
Decision Date2021-11-15
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Circul8 Pro is a medical device manufactured by Ortho8, Inc.. It received FDA 510(k) clearance on 2021-11-15 under approval number K212731. 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 Circul8 Pro?

Circul8 Pro is a medical device that received FDA 510(k) clearance on 2021-11-15. It is manufactured by Ortho8, Inc.. The 510(k) number is K212731.

When was Circul8 Pro approved by the FDA?

Circul8 Pro received FDA 510(k) clearance on 2021-11-15, under approval number K212731.

What company makes Circul8 Pro?

Circul8 Pro is manufactured by Ortho8, Inc..

What is the FDA product code for Circul8 Pro?

The FDA product code for Circul8 Pro is JOW.

Other Devices by Ortho8, Inc.

K211235CIRCUL8 Luxe DVT Prevention Device K220761CIRCUL8 Connect DVT Prevention 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.

↑