Identity
- Trade Name
- RGK Octane Sub4 FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - Titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about. FDA UDI
- Model / Reference
- Sub 4 FDA UDI
- Description
- The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - Titanium will not rust and is very resistant to corrosion and salt water. Perfect for adventures out and about. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00016958059373 FDA UDI
- 510(k) Number
- K200135 FDA UDI
- FDA Product Code
- IOR FDA UDI
- GMDN Term
- Push-rim manual wheelchair, non-bariatric FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 890.3850 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Push-rim manual wheelchair, non-bariatric
RGK Octane Sub4 by Sunrise Medical (US) LLC — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Push-rim manual wheelchair, non-bariatric.
- McKesson — MCKESSON MEDICAL-SURGICAL INC. · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- DALTON WIDE MANUAL WHEELCHAIR — Dalton Medical Corp. · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- DRIVEMEDICAL — Drive Devilbiss Healthcare · Class I
- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
- RoughRider — ROUGHRIDER AMERICA LLC · Class I
- JUDITTA — ORMESA SRL · Class I
Cleared under the same submission
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI 5bd83fd5-55a7-46e9-9496-8b8df61850a5 34 fields · synced Jun 9, 2026