RMP2 Rx Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to

GUDID 00850023296306

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

Pressure monitoring insole

• Primary Device ID: 00850023296306
• NIH Device Record Key: de1ad1b2-f46a-4035-b473-e0552413ea91
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RMP2 Rx
• Version Model Number: 7 Size (1)
• Catalog Number: Shoe insole size 1 (women 9.0 to 10.5) (men 7.0 to
• Company DUNS: 107660874
• Company Name: MEDHAB, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850023296306 [Primary]

FDA Product Code

• IKK: System, Isokinetic Testing And Evaluation

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2020-10-01
• Device Publish Date: 2020-09-23

Devices Manufactured by MEDHAB, LLC

• 00850023296009 - MyNotifi Rx: 2020-10-02 MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data i
• 00850023296016 - MyNotifi Rx: 2020-10-02 MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data i
• 00850023296023 - MyNotifi Rx: 2020-10-02 MyNotifiRX: Is a Bluetooth wearable device that interacts with a patient’s smart phone via an app (iOS or android). All data i
• 00850023296085 - STEPRITE: 2020-10-02 Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that
• 00850023296030 - STEPRITE: 2020-10-01 Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that
• 00850023296047 - STEPRITE: 2020-10-01 Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that
• 00850023296054 - STEPRITE: 2020-10-01 footbed wearable device that affords the patient the ability to perform exercises both at home and in-clinic settings that also
• 00850023296061 - STEPRITE: 2020-10-01 Is a foot bed wearable device that affords the patient the ability to perform exercises both at home and in clinic settings that