DEVICE: CAPS (B702P31C0)

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Device Identifier (DI) Information
CAPS
Professional
In Commercial Distribution
P31C
VESTIBULAR TECHNOLOGIES, LLC
B702P31C0
HIBCC

1
025647533 *Terms of Use
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.
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Device Characteristics
Labeling does not contain MRI Safety Information
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No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
63312 Biomechanical function analysis/interactive rehabilitation system
A computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).
Active false
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.
Active false
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.
Active false
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.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
KHX Platform, Force-Measuring
FRI Scale, Stand-On, Patient
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
Yes CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
7e238d9a-865a-43b2-b319-4923f79f0f65
December 09, 2019
1
December 01, 2019
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+1 307 637 5711
info@vestibtech.com
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