FDA.reportPublic FDA data

Restore Skills Therapy

Primary DI
G629RESTORESKILLSTHERA0
Brand
Restore Skills Therapy
Company
TIMOCCO USA, INC.
Model
1
Device description
Interactive rehabilitation exercise device, prescription use
Published
2024-06-27
Public version status
Update
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
G629RESTORESKILLSTHERA0PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Virtual-display routine exercise softwareA software package intended to be used on a non-medical computerized device and a display unit (e.g., television) to provide virtual exercise-based interactive activities/games for daily/regular use to help maintain or improve physical/mental health. It may be intended for use with one or more type(s) of electronic exercise device(s) [e.g., cycle device] and may provide one or more type(s) of on-screen interaction (e.g., video of a journey). It is not intended to provide specific biomechanical function analysis.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
090141480
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
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
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
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