RPM2 Rx Shoe insole size (12) (women 9.0 to 10.5) (men 7.0

GUDID 00850023296313

footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also allows the provider the ability to make clinical judgments pursuant data collected from the patient via customizable rehabilitative protocols set, and amended, by the provider.

MEDHAB, LLC

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Primary Device ID00850023296313
NIH Device Record Keyef3b4d68-7365-40c4-a201-55d4fcd1bbed
Commercial Distribution StatusIn Commercial Distribution
Brand NameRPM2 Rx
Version Model Number7 Size (12)
Catalog NumberShoe insole size (12) (women 9.0 to 10.5) (men 7.0
Company DUNS107660874
Company NameMEDHAB, LLC
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850023296313 [Primary]

FDA Product Code

IKKSystem, Isokinetic Testing And Evaluation

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-10-01
Device Publish Date2020-09-23

On-Brand Devices [RPM2 Rx]

00850023296351Is a foot bed wearable device that affords the patient the ability to perform exercises both at
00850023296344Is a foot bed wearable device that affords the patient the ability to perform exercises both at
00850023296337Is a foot bed wearable device that affords the patient the ability to perform exercises both at
00850023296320Is a foot bed wearable device that affords the patient the ability to perform exercises both at
00850023296313footbed wearable device that affords the patient the ability to perform exercises both at home a
00850023296290footbed wearable device that affords the patient the ability to perform exercises both at home a
00850023296283Is a foot bed wearable device that affords the patient the ability to perform exercises both at
00850023296276Is a foot bed wearable device that affords the patient the ability to perform exercises both at

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