Identity
- Trade Name
- Karman Healthcare FDA UDI
- Generic Name
- Handgrip disability-assistive walker, non-powered, foldable FDA UDI
- Device Name
- R-3600 3 Wheel Rollator with Large 8" Casters , Aluminum, 13lbs - Blue FDA UDI
- Model / Reference
- R-3600-BL FDA UDI
- Description
- R-3600 3 Wheel Rollator with Large 8" Casters , Aluminum, 13lbs - Blue FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00810058400161 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
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Handgrip disability-assistive walker, non-powered, foldable
Karman Healthcare by Karman Healthcare Inc. — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Handgrip disability-assistive walker, non-powered, foldable.
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- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
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- 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
- Vive Mobility — VIVE HEALTH LLC · Class I
- Drive — Drive Devilbiss Healthcare · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · 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
- Karman Healthcare Inc.
Sources (1)
- FDA UDI 7a824ef7-4677-438c-b351-9f2925b35fa3 33 fields · synced May 30, 2026