Balance Advantage Essential System

GUDID 00850017250048

Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.

BERTEC CORPORATION

Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform Posturography system platform
Primary Device ID00850017250048
NIH Device Record Key8cac9cdf-1b0f-4e6c-bf54-deebc105353d
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalance Advantage Essential System
Version Model Number97P-0001
Company DUNS619142540
Company NameBERTEC CORPORATION
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com
Phone1-614-543-8099
Emailsupport@bertec.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]
GS100850017250048 [Primary]

FDA Product Code

KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring
KHXPlatform, Force-Measuring

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-01-13
Device Publish Date2021-01-05

Devices Manufactured by BERTEC CORPORATION

00850017250000 - Bertec Vision Advantage2021-01-13 Bertec Vision Advantage (BVA) device is designed to measure changes in the visual acuity during head movements. It includes a l
00850017250017 - Balance Advantage Tender Essential System2021-01-13 Bertec Balance Advantage Tender Essential system is a clinical balance assessment device that collects and analyzes force and mo
00850017250024 - Balance Advantage Portable Functional System2021-01-13 Bertec Balance Advantage Portable Functional system is a clinical balance assessment device that collects and analyzes force and
00850017250031 - Balance Advantage Functional System2021-01-13 Bertec Balance Advantage Functional system is a clinical balance assessment device that collects and analyzes force and movement
00850017250048 - Balance Advantage Essential System2021-01-13Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate.
00850017250048 - Balance Advantage Essential System2021-01-13 Bertec Balance Advantage Essential system is a clinical balance assessment device that collects and analyzes force and movement
00850017250055 - Balance Advantage Portable essential System2021-01-13 Bertec Balance Advantage Portable Essential system is a clinical balance assessment device that collects and analyzes force and
00850017250062 - Balance Advantage Prime IVR System2021-01-13 Bertec Balance Advantage Prime IVR system is a clinical balance assessment device that collects and analyzes force and movement
00850017250079 - Balance Advantage Computerized Dynamic Posturography System2021-01-13 The Computerized Dynamic Posturography (CDP ) system is a clinical balance assessment device that collects and analyzes force an

© 2021 FDA.report
This site is not affiliated with or endorsed by the FDA.