FDA.reportPublic FDA data

Sway

Primary DI
00868168000306
Brand
Sway
Company
HEALTHY ROSTER LLC
Model
Sway Sports Plus
Published
2026-04-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
LXVApparatus, Vestibular Analysis
POMComputerized Cognitive Assessment Aid For Concussion

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LXVApparatus, Vestibular AnalysisUnknownU
POMComputerized Cognitive Assessment Aid For ConcussionNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121590000
K241737000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121590000VESTIBULAR ANALYSIS APPARATUSCapacity Sports, LLC2012-09-20LXV
K241737000Sway System Sports PlusSway Medical, Inc.2025-02-15POM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00868168000306PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00868168000306008681680003068681680003060868168000306

GMDN Terms#

Term, Definition table
TermDefinition
Cognitive assessment softwareA software program intended to be used to assess cognitive function (e.g., attention/concentration, memory) and/or to assist early detection/diagnosis of mild cognitive impairment or dementia, using cognitive tests in combination with patient demographic data. The tests are completed by the patient on an off-the-shelf computer/tablet/smartphone and test results are intended to be reviewed by a medical specialist and/or used for longitudinal analysis. It is not intended for real-time home-monitoring of dementia patients.

Regulatory Flags#

DUNS number
079916384
Device count
1
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00858458007870Korebalance MobileDiversified Healthcare Development, LLCLXV2026-04-21
00199874750514K-D BalanceKing-Devick Test, Inc.LXV2026-03-03
00860334002138ANAM Test System: Military, Military Expanded, Core, Core Expanded, and SportsVISTA PARTNERS, LLCPOM2025-11-24
00860334002121ANAM Test System: Military, Military Expanded, Core, Core Expanded, and SportsVISTA PARTNERS, LLCPOM2023-08-04
00858458007009Korebalance PremiereDiversified Healthcare Development, LLCLXV2023-07-31
00864127000356ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2021-03-05
00864127000349ImPACT Version 4IMPACT APPLICATIONS, INC.POM2021-02-27
05711117219098InteracousticsInteracoustics A/SLXV2020-05-29
00864127000325ImPACT Quick TestIMPACT APPLICATIONS, INC.POM2017-07-31
00864127000301ImPACTIMPACT APPLICATIONS, INC.POM2016-11-29
00864127000318ImPACT PediatricIMPACT APPLICATIONS, INC.POM2016-11-29