FDA.report

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
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
ISDExerciser, Measuring

Product Code Classifications

CodeDeviceSpecialtyClass
ISDExerciser, MeasuringPhysical Medicine2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
G741WHREHABV10PrimaryHIBCC0

GMDN Terms

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

Contacts

PhoneEmail
828-278-8264contact@wayahealth.com

Regulatory Flags

DUNS number
098929093
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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