Identity
- Trade Name
- RGK Octane FDA UDI
- Generic Name
- Push-rim manual wheelchair, non-bariatric FDA UDI
- Device Name
- RGK's Octane is a completely bespoke ultra-light weight titanium wheelchair for experienced users which is tailored to your unique requirements, offering exceptional energy efficiency with eye catching design. FDA UDI
- Model / Reference
- Octane FDA UDI
- Description
- RGK's Octane is a completely bespoke ultra-light weight titanium wheelchair for experienced users which is tailored to your unique requirements, offering exceptional energy efficiency with eye catching design. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 50567627057596 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 by Rgk Wheelchairs, Ltd. — 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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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
- Rgk Wheelchairs, Ltd.
Sources (1)
- FDA UDI 95d660d8-1e1a-4d2d-9691-c7407b4b49bf 34 fields · synced May 30, 2026