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RPM2 Rx

FDA UDI

Class II (US FDA UDI)

by Medhab, Llc

Identity

Trade Name
RPM2 Rx FDA UDI
Generic Name
Pressure monitoring insole FDA UDI
Device Name
Is a foot bed 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. FDA UDI
Model / Reference
7 Size (00) FDA UDI
Description
Is a foot bed 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. FDA UDI

Identifiers

Catalog Number
Shoe insole size 00 (women 3.0 to 6.5) FDA UDI
Primary DI / UDI-DI
00850023296283 FDA UDI
FDA Product Code
IKK FDA UDI
GMDN Term
Pressure monitoring insole FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.1925 FDA UDI
Commercial Distribution
Not in Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

RPM2 Rx by Medhab, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Medhab, Llc

Sources (1)

  • FDA UDI 346a8875-55c1-4e4d-a8bc-82d199fee84a 35 fields · synced May 31, 2026