CAPS - Lightweight, portable, state of the art - VESTIBULAR TECHNOLOGIES, LLC

Duns Number:025647533

Device Description: Lightweight, portable, state of the art three-component force platform, measuring the vert Lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). Its large surface allows for any stance. It is sensitive enough to pick up the changes in the vertical ground reaction force produced by the beating of the heart and the blood ejection in the aorta (including the modulation produced by the breathing cycle), while the subject is standing on the top surface. It satisfies the International Society for Posture and Gait Research (ISPGR) recommendations for clinical posturography. It is intended to be used as aid in fall risk screening; posturography (static and dynamic); weight, balance, and postural control assessment; mechanography; physical performance investigations; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.

Want to know more about this Product? Request more information now!


More Product Details

Catalog Number

P31C

Brand Name

CAPS

Version/Model Number

Professional

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In HIBCC

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

FRI

Product Code Name

Scale, Stand-On, Patient

Device Record Status

Public Device Record Key

7e238d9a-865a-43b2-b319-4923f79f0f65

Public Version Date

December 09, 2019

Public Version Number

1

DI Record Publish Date

December 01, 2019

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VESTIBULAR TECHNOLOGIES, LLC" Characteristics
Device Class Device Class Description No of Devices
1 A medical device with low to moderate risk that requires general controls 2