ManoFX Right ManoFX-R

GUDID 00810113683201

The ManoFX is a wrist hand finger orthosis. The unique design allows fractures of the hand and finger to be positioned for optimum healing. This innovative approach allows customization of the brace to be configured as a Boxer's fracture splint (ulnar gutter splint), Radial Gutter splint, or a Buddy finger splint (metacarpal fracture brace). Features: Malleable aluminum stays Split dorsal stay Soft breathable body Wraparound design for customized fit

Manamed, Inc.

Wrist/hand/finger stable-position orthosis

• Primary Device ID: 00810113683201
• NIH Device Record Key: d4611dec-4468-4eba-ada3-7e92641ed612
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ManoFX Right
• Version Model Number: ManoFX-R
• Catalog Number: ManoFX-R
• Company DUNS: 084042331
• Company Name: Manamed, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: true

Customer Support Contacts

• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com
• Phone: 888-508-0712
• Email: support@manamed.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00810113683201 [Primary]

FDA Product Code

• ILH: Splint, Hand, And Components

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: 2025-10-06
• Device Publish Date: 2025-09-26

Devices Manufactured by Manamed, Inc.

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• 00810113684161 - ManaEZ Wrist Left, Extra Small: 2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
• 00810113684178 - ManaEZ Wrist Right, Extra Large: 2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
• 00810113684185 - ManaEZ Wrist Right, Extra Small: 2026-02-09 The ManaEZ wrist is a high quality, wrist brace. Patent pending single pull system makes it easier for the user to self-apply th
• 00810113683065 - ManaEZ ROM Ice Short: 2026-01-12 ManaEZ ROM Ice is a quick fitting, universal, knee range of motion orthosis with compression and a flexible ice pack. The brace
• 00810113683515 - ManaEZ Hip Ice CureTech: 2026-01-12 ManaEZ Hip Ice is a quick fitting, universal, hip range of motion orthosis. The brace includes range of motion hinges to allow f
• 00810113683522 - ManaEZ ROM Ice CureTech: 2026-01-12 ManaEZ ROM is a quick fitting, universal, knee range of motion orthosis. The brace includes range of motion hinges to allow for
• 00810113683539 - ManaEZ Shoulder Ice CureTech: 2026-01-12 The ManaEZ Shoulder ice a convenient shoulder orthosis for pain, swelling, and to compress the shoulder joint. Pump up with air