Identity
- Trade Name
- RGK Octane FX FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- The RGK Octane FX is a made-to-measure chair unlike any other. Imagine a wheelchair that folds down so small you can store it in most airplane overhead luggage compartments. Imagine a wheelchair that is as lightweight and performance-oriented as a rigid sports chair. FDA UDI
- Model / Reference
- FX FDA UDI
- Description
- The RGK Octane FX is a made-to-measure chair unlike any other. Imagine a wheelchair that folds down so small you can store it in most airplane overhead luggage compartments. Imagine a wheelchair that is as lightweight and performance-oriented as a rigid sports chair. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00016958060249 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 FX 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.
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- Probasics — COMPASS HEALTH BRANDS CORP. · Class I
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- 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 |
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Manufacturer
- Manufacturer
- Sunrise Medical (US) LLC
Sources (1)
- FDA UDI 5fdf6e04-0529-4fb5-8653-3a696881d26c 34 fields · synced Jun 9, 2026