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FDA 510(k)

ClearEdge Balance System

K-Number: K183661 · 2019-10-22

ApplicantQuadrant Biosciences
Decision Date2019-10-22
Product CodeLXV
DecisionSubstantially Equivalent

Device Summary

ClearEdge Balance System is a medical device manufactured by Quadrant Biosciences. It received FDA 510(k) clearance on 2019-10-22 under approval number K183661. The device is classified under product code LXV. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ClearEdge Balance System?

ClearEdge Balance System is a medical device that received FDA 510(k) clearance on 2019-10-22. It is manufactured by Quadrant Biosciences. The 510(k) number is K183661.

When was ClearEdge Balance System approved by the FDA?

ClearEdge Balance System received FDA 510(k) clearance on 2019-10-22, under approval number K183661.

What company makes ClearEdge Balance System?

ClearEdge Balance System is manufactured by Quadrant Biosciences.

What is the FDA product code for ClearEdge Balance System?

The FDA product code for ClearEdge Balance System is LXV.

Related Clinical Trials

NCT07612332 Non-Immersive Virtual Reality for Gait and Balance Training in Children With Cerebral Palsy NOT_YET_RECRUITING NCT07603609 Sensorimotor Training With a Mobilized Balance Platform in Patients With Chronic Low Back Pain RECRUITING NCT07034521 The Feasibility and Therapeutic Effect of Hybrid End-effector Robot-assisted Gait Training With an Active-assisted Module in Chronic Stroke Survivors RECRUITING NCT07593807 TMS Combined With Virtual Reality and Multidisciplinary Rehabilitation in Multiple Sclerosis ACTIVE_NOT_RECRUITING NCT05235113 Remote Game-based Exercise Program for Cognitive and Motor Function Improvement ACTIVE_NOT_RECRUITING NCT07575425 Effects of Mobilized Balance Platform Exercises on Balance Parameters in Patients With Knee Osteoarthritis RECRUITING

Related Devices (Code: LXV)

K173669K-D BalanceKing-Devick Technologies, Inc. K190735EQ BalanceUpright Science, Inc. K200529OrionInteracoustics A/S K192652TRVInteracoustics A/S K220231GyroStimUltrathera Technologies, Inc.

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.

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