Orpyx Sensory Insoles

Basic Information

• Brand Name: Orpyx Sensory Insoles
• Primary DI: 10185571000196
• Version / Model: WTXPOD1
• Catalog Number: 10185571000196
• Company Name: Orpyx
• Labeler DUNS: 250917031
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-02-07
• Public Version: 1
• Public Version Date: 2025-02-17
• Public Version Status: New
• Public Device Record Key: 2fd59d7e-ac6a-4c60-8ecf-b4363ca29cfc

Device Description

Orpyx Sensory Insoles wireless charger and wall adapter replacement which is part of Orpyx Sensory Insole system. The charger enables the user to charge their Orpyx Sensory Insoles.

Device Characteristics

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

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
IRN	Device, Warning, Overload, External Limb, Powered	Physical Medicine	890.5575	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64667	Noninvasive device battery charger/transceiver/cable	An electrically-powered device designed to supply an electrical charge to the battery of a noninvasive device to recharge it for operation, and to both receive data from and transmit data to noninvasive devices via a direct/wired or wireless connection. It is typically in the form of an electronic circuitry housing with a cable.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10185571000196	GS1