FDA.reportPublic FDA data

Waya Rehab

Primary DI
G741WHREHABV10
Brand
Waya Rehab
Company
WELLOVATE, LLC
Model
1
Device description
Waya® Rehab is a software only medical device to support rehabilitation under the guidance of a qualified healthcare professional.
Published
2025-02-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ISDExerciser, Measuring

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
G741WHREHABV10PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Biomechanical function analysis/interactive rehabilitation systemA computerized device assembly designed for: 1) analysis of biomechanical/neuromuscular function using dedicated hardware; and 2) neuromuscular rehabilitation therapy at multiple anatomical sites based on patient interaction with dedicated physical-response measuring hardware (e.g., dynamometer, standing force plates, EMG electrodes) providing feedback in a videogame-like format. It includes multiple pieces of neuromuscular function analysis and physical-response measuring hardware, computer interface devices and dedicated software; it is intended to be used with an off-the-shelf computer. It is not based on tracking movement through space (i.e., not a virtual-display rehabilitation system).

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
828-278-8264contact@wayahealth.com

Regulatory Flags#

DUNS number
098929093
Device count
1
Premarket exempt
true
Lot or batch
true

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00850000967649SpiroFitCMI HEALTH INC.ISD2026-03-06
00853858006522EmbraceMiniEMPATICA SRLISD2026-02-16
00853858006713EmbraceMiniEMPATICA SRLISD2026-02-16
07290016986174XRBehaviorXR HEALTH IL LTDISD2026-01-26
07290016986181XRBehaviorXR HEALTH IL LTDISD2026-01-26
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00850064651102DS6Foresite Healthcare, LLCISD2025-02-07
00860010613320StrideLink MercuryStrideLink Inc.ISD2024-12-16
G186EXERSCAN20Exer ScanExer Labs, Inc.ISD2024-09-03
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00850067173014Docking Station V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173021Access Point V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850067173038Opal DataHub V2CAPDM WEARABLE TECHNOLOGIES, INC.ISD2024-08-30
00850064651003DS5Foresite Healthcare, LLCISD2024-05-24
00850064651010DS6Foresite Healthcare, LLCISD2024-05-24
00850064651027MDSForesite Healthcare, LLCISD2024-05-24
00850064651041DS6Foresite Healthcare, LLCISD2024-05-24
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00850064651065DS6Foresite Healthcare, LLCISD2024-05-24