Identity
- Trade Name
- STEPRITE 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 (0) 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 0 (women 7.0 to 8.5) (men 5.0 to 6.5) FDA UDI
- Primary DI / UDI-DI
- 00850023296047 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
- 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
Category: Pressure monitoring insole
Steprite by Medhab, Llc — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Medhab, Llc
Sources (1)
- FDA UDI 469a5d4a-30fe-4089-bc61-65969c318e67 34 fields · synced May 30, 2026