FDA.reportPublic FDA data

Podimetrics SmartMat+

Primary DI
00866538000338
Brand
Podimetrics SmartMat+
Company
Podimetrics, Inc.
Model
PMHS300U
Catalog number
PMHS300U
Published
2025-12-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
OIZFoot Examination Tool For Inflammatory Changes

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
OIZFoot Examination Tool For Inflammatory ChangesPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00866538000338PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00866538000338008665380003388665380003380866538000338

GMDN Terms#

Term, Definition table
TermDefinition
Continuous electronic patient thermometer, battery-poweredA battery-powered, electronic instrument designed to continuously measure (monitor) a patient's body temperature (e.g., during the administration of general anaesthesia, treatment of hypothermia and hyperthermia). It comprises an electronic unit and an attached probe that detects and converts the changes in temperature into variations of an electric characteristic, e.g., resistance or voltage. These variations of the electric characteristic are processed in the electronic circuits and continuously displayed as temperature readings. This is a reusable device.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature-20 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(617) 616-5269info@podimetrics.com

Regulatory Flags#

DUNS number
078861191
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00866538000321Podimetrics Wi-Fi SmartMatPMHS230UPMHS230U2024-04-06
00866538000307Podimetrics SmartMatPMHS201UPMHS201U2021-09-07
00866538000314Podimetrics Remanufactured SmartMatPMHS201U-RPMHS201U-R2021-09-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860013816506Empo FootprintEmpo Health, Inc.OIZ2025-07-31
10185571000172Orpyx Flex Sensory InsolesOrpyxOIZ2025-02-07
10185571000332Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000349Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000356Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000363Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000400Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000417Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000462Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000479Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000486Orpyx Sensory InsolesOrpyxOIZ2025-02-07
10185571000493Orpyx Sensory InsolesOrpyxOIZ2025-02-07
00866538000321Podimetrics Wi-Fi SmartMatPodimetrics, Inc.OIZ2024-04-06
05391536710002Bluedrop MedicalBLUEDROP MEDICAL LIMITEDOIZ2023-09-18
00866538000307Podimetrics SmartMatPodimetrics, Inc.OIZ2021-09-07
00866538000314Podimetrics Remanufactured SmartMatPodimetrics, Inc.OIZ2021-09-07