CAPS - Compact, lightweight, portable, state of the art - VESTIBULAR TECHNOLOGIES, LLC

Duns Number:025647533

Device Description: Compact, lightweight, portable, state of the art three-component force platform, measuring

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More Product Details

Catalog Number

P32C

Brand Name

CAPS

Version/Model Number

Lite

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

b4be2289-6af5-43c6-994b-af368b4a0b5e

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