Identity
- Trade Name
- Probasics FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- Nighthawk XR Rollator, Black (Adjustable Height - Euro Style 450LB WT Cap) FDA UDI
- Model / Reference
- RLEU10BK-SXR FDA UDI
- Description
- Nighthawk XR Rollator, Black (Adjustable Height - Euro Style 450LB WT Cap) FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00815067078844 FDA UDI
- FDA Product Code
- ITJ FDA UDI
- GMDN Term
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3825 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
Yes
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
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Handgrip disability-assistive walker, non-powered, foldable
Probasics by Compass Health Brands Corp. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Handgrip disability-assistive walker, non-powered, foldable.
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Giloga — Zhongshan Jiale Rehabilitation Medical Equipment Co., Ltd · Class I
- Bariatric Dual Release Folding Walker — Dynarex Corp. · Class I
- DMECARE Solutions Two Button Folding Walkers, Junior, 25" - 32", With 5" Wheels — Dynarex Corp. · Class I
- Karman Healthcare — KARMAN HEALTHCARE INC. · Class I
- Vive Mobility — VIVE HEALTH LLC · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Drive — Drive Devilbiss Healthcare · Class I
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 I | Pending data |
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Manufacturer
- Manufacturer
- Compass Health Brands Corp.
Sources (1)
- FDA UDI 0140c8b3-87ae-403b-b10b-6863ddaefdcb 34 fields · synced Jun 6, 2026