FDA.reportPublic FDA data

3DGait

Primary DI
08883000011311
Brand
3DGait
Company
CARECAM PTE. LTD.
Model
1.x
Published
2026-04-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe

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
08883000011311PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08883000011311088830000113118883000011311

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.

Regulatory Flags#

DUNS number
659992147
Device count
1
Premarket exempt
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
G693YSV10YourSteps Yoursteps Health, Inc.QKC2026-04-30
03760272650699MindMotion Toap Run NeuroXtherapeutics SAQKC2026-04-13
03760272650880MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-23
03760272650774MindMotion GO Procedure PackNeuroXtherapeutics SAQKC2026-03-16
05694230564040NeckCare HomeNeckCare Holding ehfQKC2026-03-09
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