Balance Advantage Tender Essential System

GUDID 00850017250017

Bertec Balance Advantage Tender 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 ID00850017250017
NIH Device Record Key9148fc84-9854-4775-be93-556156f2bbe3
Commercial Distribution StatusIn Commercial Distribution
Brand NameBalance Advantage Tender Essential System
Version Model Number97P-0045
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
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [Primary]
GS100850017250017 [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

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00850017250017 - Balance Advantage Tender Essential System2021-01-13Bertec Balance Advantage Tender Essential system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate
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 System2021-01-13 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

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