FDA.reportPublic FDA data

Bertec Head Mounted Display System (HMD)

Primary DI
00850017250116
Brand
Bertec Head Mounted Display System (HMD)
Company
BERTEC CORPORATION
Model
97P-0109
Device description
Bertec Balance Advantage Head Mounted Display (HMD) system is a clinical balance assessment device that collects and analyzes force and movement data from a static balance plate with Head Mounted Display (HMD) to enhance clinical balance assessment and training.
Published
2023-02-08
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring
KHXPlatform, Force-Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2
KHXPlatform, Force-MeasuringPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850017250116PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850017250116008500172501168500172501160850017250116

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used to detect and display a patient’s physical exercise/movements/actions, and sometimes provide performance feedback, while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology ambulatory recorder, as part of physical assessment/rehabilitation. It might be intended to function in conjunction with a motion-sensing system/device or limb-support robotic system, and may be capable of storing patient performance data.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-614-543-8099support@bertec.com

Regulatory Flags#

DUNS number
619142540
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850017250017Balance Advantage Essential Spark System97P-00772021-01-05
00850017250031Balance Advantage Functional System97P-00052021-01-05
00850017250093Bertec Vision Trainer System (BVT)95P-001495P-00142022-01-24
00850017250000Bertec Vision Advantage97P-00372021-01-05
00850017250024Balance Advantage Portable Functional System97P-00662021-01-05
00850017250048Balance Advantage Essential System97P-00012021-01-05
00850017250055Balance Advantage Portable essential System97P-00022021-01-05
00850017250062Balance Advantage Prime IVR System97P-00722021-01-05
00850017250079Balance Advantage Computerized Dynamic Posturography System97P-00362021-01-05

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08717524641092Lode B.V.Lode B.V.ISD2026-06-01
07649998859059NUSHUMagnes AGISD2026-05-31
07290016986211XRBehaviorXR HEALTH IL LTDISD2026-05-14
07290016986204XRBehaviorXR HEALTH IL LTDISD2026-05-04
00199874272399SeniorLife.AISENIORLIFE TECHNOLOGIES INC.ISD2026-03-11
00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
00860014763700Aspire MotionSurge Motion Inc.ISD2025-11-14
G186EXERSCAN30Exer ScanExer Labs, Inc.ISD2025-11-10
00860004615606XR Therapy SystemNeuromersive, Inc.ISD2025-10-25
00810188050045Bioness Integrated Therapy System, BITS 3.0, BITS BalanceBioness Medical, Inc.ISD2025-07-18
00616784050218Pedal Exerciser, Folding, Digital, Hands/FeetDynarex CorporationISD2025-05-29
08908024776005EQUIPOISEEQUIDOR MEDTECH LLPKHX2025-02-19
00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
G741WHREHABV10Waya RehabWELLOVATE, LLCISD2025-02-03
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
00850067173007Opal V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24