RGK Octane Sub4

GUDID 50567627059378

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.

RGK WHEELCHAIRS LIMITED

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• Primary Device ID: 50567627059378
• NIH Device Record Key: 4858d2e7-08c5-4000-bc3f-0e828c7a913b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: RGK Octane Sub4
• Version Model Number: Sub4
• Company DUNS: 216729066
• Company Name: RGK WHEELCHAIRS LIMITED
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	50567627059378 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K200135

FDA Product Code

• IOR: Wheelchair, Mechanical

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-02-13
• Device Publish Date: 2024-02-05

Devices Manufactured by RGK WHEELCHAIRS LIMITED

• 50567627057596 - RGK Octane: 2024-02-13 RGK's Octane is a completely bespoke ultra-light weight titanium wheelchair for experienced users which is tailored to your uniq
• 50567627059378 - RGK Octane Sub4: 2024-02-13The 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.
• 50567627059378 - RGK Octane Sub4: 2024-02-13 The Sub4 is an ultra lightweight and rigid wheelchair that is perfectly designed to fit you and your lifestyle. No corrosion - t
• 50567627060244 - RGK Octane FX: 2024-02-13 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