Model: 560X18-1=ANDR
DI: 04064411004343
Status: New
MRI: Labeling does not contain MRI Safety Information
Single-use: No
Rx: No
OTC: No
First Published: 2026-05-04
Current Version: 2026-05-12
Sterilization
Device Sterile:
No
Sterilization Prior To Use:
No
Regulatory & Distribution
Record Status:
Published
Version Number:
1
Record Key:
ee69b889-0ce9-41a5-a2e6-f755a7356064
Distribution Status:
In Commercial Distribution
DUNS Number:
300802068
Device Count:
1
DM Exempt:
No
Premarket Exempt:
No
HCT/P:
No
Kit:
No
Combination Product:
No
Lot/Batch Tracked:
No
Serial Number Tracked:
No
Manufacturing Date Tracked:
Yes
Expiration Date Tracked:
No
Donation ID Number Tracked:
No
Labeled Contains NRL:
No
Labeled No NRL:
No
Identifiers
Device ID:
04064411004343
Type:
Primary
Issuing Agency:
GS1
GMDN
Code: 64734
Name: External limb prosthesis adjustment software
Definition:
A software program designed for use with an electronic external limb prosthesis intended to enable the amputee and clinician to adjust the prosthesis settings (e.g., motion control preferences, programming of pre-set modes for different activities). It is intended to be used on a non-medical computerized device (e.g., smartphone, tablet) for wireless communication with the prosthesis.
FDA Product Codes
GXY
Electrode, Cutaneous
IQZ
Hand, External Limb Component, Powered