K-D Balance

Primary DI
00199874750514
Brand
K-D Balance
Company
King-Devick Test, Inc.
Model
2.0
Catalog number
2.0
Device description
Software used in smart phone to determine balance
Published
2026-03-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Product Codes#

Code, Name table
CodeName
LXVApparatus, Vestibular Analysis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXVApparatus, Vestibular AnalysisUnknownU

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173669000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173669000K-D BalanceKing-Devick Technologies, Inc.2018-04-02LXV

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00199874750514PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00199874750514001998747505141998747505140199874750514

GMDN Terms#

Term, Definition table
TermDefinition
Sports concussion screening softwareA software program intended to be used on a non-medical computerized device (e.g., smartphone, tablet) to measure, record, and display a range of psychophysical parameters (e.g., eye movement, attention, speech, concentration) for the evaluation of sports-acquired concussions. It provides a visual stimulus test (e.g., text for audible reading) and is intended to be used sideline by laypersons (e.g., sports coach) or medical professionals and during contact or collision sports events to rapidly screen a patient for head trauma injuries; it does not require clinical consultation prior to use.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
964658723
Device count
1
No natural rubber latex
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858458007870Korebalance MobileDiversified Healthcare Development, LLCLXV2026-04-21
00868168000306SwayHEALTHY ROSTER LLCLXV2026-04-13
00858458007009Korebalance PremiereDiversified Healthcare Development, LLCLXV2023-07-31
05711117219098InteracousticsInteracoustics A/SLXV2020-05-29