CAPS

Basic Information

• Brand Name: CAPS
• Primary DI: B702P32C0
• Version / Model: Lite
• Catalog Number: P32C
• Company Name: VESTIBULAR TECHNOLOGIES, LLC
• Labeler DUNS: 025647533
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-12-01
• Public Version: 1
• Public Version Date: 2019-12-09
• Public Version Status: New
• Public Device Record Key: b4be2289-6af5-43c6-994b-af368b4a0b5e

Device Description

Compact, lightweight, portable, state of the art three-component force platform, measuring the vertical ground reaction force and its point of application (CoP). 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; and objective tracking of treatment efficacy and disease progress. Covered by one or more US patents.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
FRI	Scale, Stand-On, Patient	General Hospital	880.2700	1
KHX	Platform, Force-Measuring	Physical Medicine	890.1575	1

GMDN Terms

Code	Name	Definition	Implantable	Status
17242	Posturography system	An assembly of devices designed to test a patient's sensory, voluntary, and/or reflexive motor control of balance and mobility providing biofeedback for rehabilitation of balance problems. The patient is placed on a dedicated platform equipped with built-in sensors, transducer and/or force plates that register movement when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output is recorded to a computer where they are graphically reproduced. This device is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies.	No	Active
38211	Stand-on floor scale, electronic	An electrically-powered device designed to be placed on/integrated into the floor and upon which a patient is intended to stand to measure and display total body weight. It is not designed to weigh a wheelchair-bound patient or bed/stretcher.	No	Active
43114	Posturography system platform	A device that is a component of a balance/mobility management system equipped with built-in sensors, transducer and/or force plates that register movement of the patient when he/she adjusts his/her centre of gravity (COG) alignment according to the doctor's instructions, or, the platform provokes destabilizing perturbations and the output of these movements are measured and recorded to the system computer. It is used, e.g., for motor control test (MCT), posture studies, balance, mobility training, and/or sense of equilibrium studies. The patient will stand on this device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B702P32C0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]