FDA UDI In Commercial Distribution 🇺🇸 United States

ARYS pro

DI: 09120077180120 · Model: 3 · tyromotion GmbH
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1

Basic Information

Brand Name
ARYS pro
Primary DI
09120077180120
Version / Model
3
Company Name
tyromotion GmbH
Labeler DUNS
301726803
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2022-09-18
Public Version
2
Public Version Date
2024-02-05
Public Version Status
Update
Public Device Record Key
b7e4ec32-0be5-46f7-81b5-a65a3322f7c0

Device Description

ARYS pro is intended to track and organize patient health and activity information recorded by sensors on the paretic and healthy wrist and using a mobile app for visualization.

Device Characteristics

Single Use
No
Prescription Use (Rx)
No
Over the Counter (OTC)
No
Kit
No
Combination Product
No
HCT/P
No
Contains NRL
No
Not Made with NRL
No
MRI Safety
Labeling does not contain MRI Safety Information
Direct Marking Exempt
No
PM Exempt
Yes
Has Serial Number
Yes
Has Lot/Batch Number
No
Has Manufacturing Date
No
Has Expiration Date
No
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
ION Exerciser, Non-Measuring

GMDN Terms

Code Name
47518 Biomechanical function analysis/rehabilitation software

Identifiers

Type ID
Primary 09120077180120