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

Podimetrics Remanufactured SmartMat

Name: Podimetrics Remanufactured SmartMat
Brand: Podimetrics Remanufactured SmartMat

Catalogue number PMHS201U-R, listed by Podimetrics, Inc., United States, under Foot Examination Tool For Inflammatory Changes. 1 manufacturer in China is registered for this product code.

Registry build 21.09.26

1manufacturer

1catalogue number

1510(k) clearance

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 Podimetrics Remanufactured SmartMat
Listed by	Podimetrics, Inc., United States
FDA product code	OIZ
Device type	Foot Examination Tool For Inflammatory Changes
Device class	Class 1
Regulation	21 CFR 890.5050
Establishment	Specification developer, Complaint-file establishment, Manufacturer
Record published	2021-09-07

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	manufacturing date, serial number
Storage	Storage environment temperature -20 to 45 °C

Catalogue Numbers

Catalogue numbers for Podimetrics Remanufactured SmartMat
Catalogue number	Size	Status
PMHS201U-R		In distribution

Same Product Code

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

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K150557	2015-10-08

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.