FDA.report

FeetMe Monitor Charging Case FTM-DK-CC

Primary DI
03760349820109
Brand
FeetMe Monitor Charging Case FTM-DK-CC
Company
FEETME
Model
V1
Device description
This device is a charging and transportation case for up to 12 pair of FTM-DK insoles
Published
2022-11-11
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
JFCSystem, Pressure Measurement, Intermittent

Product Code Classifications

CodeDeviceSpecialtyClass
JFCSystem, Pressure Measurement, IntermittentPhysical Medicine1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03760349820109PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
03760349820109037603498201093760349820109

GMDN Terms

TermDefinition
Noninvasive device battery chargerAn electrically-powered device designed to supply an electrical charge, via a direct/wired or wireless connection, to the battery of a noninvasive device to recharge it for operation; it is not intended to receive data from and transmit data to other devices (i.e., not a transceiver). It is typically in the form of an electronic circuitry housing with a cable.

Storage And Handling

TypeLowHighCondition
Handling Environment Temperature5 Degrees Celsius35 Degrees Celsius
Storage Environment Temperature-25 Degrees Celsius70 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
265478109
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03760349820093FeetMe Monitor FTM-DKPVT32023-03-24
03760349820130FeetMe Monitor Charging Case FTM-DK-CCV42023-03-17
03760349820000FeetMe Monitor FTM-DKPVT12022-11-11
03760349820024FTM-REHAB-IA12022-11-11
03760349820086FeetMe Monitor FTM-DKPVT22022-11-11
03760349820062FTM-EVAL-AA32022-11-11
03760349820116FeetMe Monitor Charging Case FTM-DK-CCV22022-11-11
03760349820123FeetMe Monitor Charging Case FTM-DK-CCV32022-11-11

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