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)

REPROCESSED RESTEP COMPRESSION SLEEVES

K-Number: K101087 · 2010-07-16

ApplicantAscent Heatlhcare Solutions
Decision Date2010-07-16
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPROCESSED RESTEP COMPRESSION SLEEVES is the device name listed in this FDA 510(k) record. The listed applicant is Ascent Heatlhcare Solutions. It received FDA 510(k) clearance on 2010-07-16 under 510(k) number K101087. 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 REPROCESSED RESTEP COMPRESSION SLEEVES?

REPROCESSED RESTEP COMPRESSION SLEEVES is a medical device that received FDA 510(k) clearance on 2010-07-16. The listed applicant is Ascent Heatlhcare Solutions. The 510(k) number is K101087.

When did REPROCESSED RESTEP COMPRESSION SLEEVES receive FDA 510(k) clearance?

REPROCESSED RESTEP COMPRESSION SLEEVES received FDA 510(k) clearance on 2010-07-16, under 510(k) number K101087.

Who is the listed applicant for REPROCESSED RESTEP COMPRESSION SLEEVES?

The FDA 510(k) record lists Ascent Heatlhcare Solutions as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for REPROCESSED RESTEP COMPRESSION SLEEVES?

The FDA product code for REPROCESSED RESTEP COMPRESSION SLEEVES is JOW.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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.

K261807Sequential Circulator (SC-4004-DL, SC-4008-DL)Bio Compression Systems, Inc.K254217AerloomEvolym, LLCK253555Flexitouch® Plus Advanced Pneumatic Compression SystemTactile MedicalK253386DVT GarmentVistar Medical Supplies Co., Ltd.K250242Compression Therapy Device (LGT-2202DVT)Guangzhou Longest Medical Technology Co., Ltd.K254267NanoPress 760A-BT (760A-BT)Mego Afek , Ltd.

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.

↑