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)

ElastiMed SACS

K-Number: K232300 · 2023-12-22

ApplicantElastimed , Ltd.
Decision Date2023-12-22
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ElastiMed SACS is a medical device manufactured by Elastimed , Ltd.. It received FDA 510(k) clearance on 2023-12-22 under approval number K232300. 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 ElastiMed SACS?

ElastiMed SACS is a medical device that received FDA 510(k) clearance on 2023-12-22. It is manufactured by Elastimed , Ltd.. The 510(k) number is K232300.

When was ElastiMed SACS approved by the FDA?

ElastiMed SACS received FDA 510(k) clearance on 2023-12-22, under approval number K232300.

What company makes ElastiMed SACS?

ElastiMed SACS is manufactured by Elastimed , Ltd..

What is the FDA product code for ElastiMed SACS?

The FDA product code for ElastiMed SACS is JOW.

Other Devices by Elastimed , Ltd.

K243177SACS PRO

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.

↑