FDA.reportPublic FDA data

NeckCare Home

Primary DI
05694230564040
Brand
NeckCare Home
Company
NeckCare Holding ehf
Model
v1
Device description
The NeckCare Home is used to provide prescribed neck movement exercises and measure, record, analyze, and report head motion during instructed head-neck movements.
Published
2026-03-09
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
QKCInteractive Rehabilitation Exercise Device, Prescription Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QKCInteractive Rehabilitation Exercise Device, Prescription UsePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05694230564040PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05694230564040056942305640405694230564040

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/rehabilitation softwareA software package intended to be used by patients and clinicians to receive and display a patient’s physical exercise/movement/action data [e.g., kinesiology/gait data (walking speed or distance)] to facilitate analysis as part of physical assessment/rehabilitation. It is intended to be used while using an interactive rehabilitation system, biomechanical function analysis system and/or kinesiology recorder (ambulatory or implantable). 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 and/or enable viewing of patient performance data.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
500824286
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05694230564002NeckCare Assessmentsv22025-05-30
05694230564026NeckCare Exercisesv22025-05-30
05694230564033NeckCare DeviceNS-110X22025-05-30
05694230564019NeckCare SystemNS-110X22023-08-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G693YSV10YourSteps Yoursteps Health, Inc.QKC2026-04-30
088830000113113DGaitCARECAM PTE. LTD.QKC2026-04-22
03760272650699MindMotion Toap Run NeuroXtherapeutics SAQKC2026-04-13
03760272650880MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-23
03760272650774MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-16
07290020097040Kemtai CareKEMTAI LTDQKC2026-02-05
07290020097002Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097019Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097026Kemtai CareKEMTAI LTDQKC2025-12-23
07290020097033Kemtai CareKEMTAI LTDQKC2025-12-23
05065012458138Strolll RehabSTROLLL LIMITEDQKC2025-12-16
00860011881711Proactive StridesVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
00860011881728Proactive YouVIRTUSENSE TECHNOLOGIES, INC.QKC2025-12-01
05694230564026NeckCare ExercisesNeckCare Holding ehfQKC2025-05-30
05391548420005VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420012VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-23
05391548420029VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05391548420036VertigeniusDIGITAL REHABILITATION LIMITEDQKC2025-02-20
05065012458114Reality DTxSTROLLL LIMITEDQKC2024-07-08
05065012458121Reality DTxSTROLLL LIMITEDQKC2024-07-08
G629RESTORESKILLSTHERA0Restore Skills TherapyTIMOCCO USA, INC.QKC2024-06-27
00860011881704VSTBalanceVIRTUSENSE TECHNOLOGIES, INC.QKC2024-06-10
08809970060005EverEx RehabEverExQKC2024-04-03
00196852042524Motion TrainerTrainer Rx, Inc. D/B/A RecoveryoneQKC2023-08-29
05065012458039Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065012458046Reality DTxSTROLLL LIMITEDQKC2023-08-22
05065010464001GaitSmart®DYNAMIC METRICS LIMITEDQKC2023-05-17
G186EXERHEALTH20Exer HealthExer Labs, Inc.QKC2023-03-21
00860008232304EnGauge Physical Rehabilitation SystemVerity Technologies, Inc.QKC2022-08-10
G186EXERPHYSIO20Exer PhysioExer Labs, Inc.QKC2022-01-04