What is FDA product code OIZ?

Assist a patient to visualize the image and condition of the soles of their feet in connection with a daily self-examination for signs of inflammation on the sole of the foot. The device will assist the patient in determining when they should contact their healthcare provider for further diagnosis and treatment regarding any skin changes seen by a mirror and/or highlighted by the liquid crystal foot pads. Intended to be used as an adjunct to, and not in replacement of, periodic foot care and examinations conducted by a health care professional and used under the direction of a health care professional and does not diagnose any specific disease state.

Physical Medicine › TherapeuticFoot Examination Tool For Inflammatory Changes

Orpyx Sensory Insoles

Name: Orpyx Sensory Insoles
Brand: Orpyx Sensory Insoles

The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole…

Registry build 21.09.26

The Orpyx® Custom Sensory Insole renewal is a pair of custom sensory insoles with 4 months of remote patient monitoring support. The renewal insoles work as part of the Orpyx Sensory Insole system. The following is included: 1 pair of custom insoles – Instructions for use manual – 4 months of RPM support – 3rd party contracted scanning, fitting and dispensing support

1manufacturer

1catalogue number

Who Else Makes It

Registered in Zhejiang.

Chinese manufacturers registered for FDA product code OIZ
Manufacturer	City	Province	Registered as	Device types
Ningbo Weifeng Houseware Co., Ltd.	Ningbo	Zhejiang	Manufacturer	5

Record

Regulatory record for Orpyx Sensory Insoles
Listed by	Orpyx Medical Technologies Inc., Canada
FDA product code	OIZ
Device type	Foot Examination Tool For Inflammatory Changes
Device class	Class 1
Regulation	21 CFR 890.5050
Establishment	Complaint-file establishment, Manufacturer
Premarket notification	Exempt
Record published	2025-02-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, serial number

Catalogue Numbers

Catalogue numbers for Orpyx Sensory Insoles
Catalogue number	Size	Status
ORPYXSIV1		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Podimetrics SmartMat+	Podimetrics, Inc.	2
Podimetrics Remanufactured SmartMat	Podimetrics, Inc.	1
Bluedrop Medical	Bluedrop Medical Ltd	1
Podimetrics Wi-Fi SmartMat	Podimetrics, Inc.	1
Empo Footprint	Empo Health, Inc.	1

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.