Mouthflex

GUDID 00860014768620

MouthFlex is indicated for rehabilitating jaw and lip mobility in patients suffering from trismus (lockjaw), TMJ disorders, facial burns, or post-radiation fibrosis

INNOMOTIVE L.L.C

Mastication muscle exerciser

• Primary Device ID: 00860014768620
• NIH Device Record Key: 60008707-8352-45b2-ae11-e2775fbc3de5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Mouthflex
• Version Model Number: MF100
• Company DUNS: 122432830
• Company Name: INNOMOTIVE L.L.C
• 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: 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	00860014768620 [Primary]

FDA Product Code

• ION: Exerciser, Non-Measuring

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: 2026-02-19
• Device Publish Date: 2026-02-11

Devices Manufactured by INNOMOTIVE L.L.C

• 00860014768606 - QuickBrace: 2026-02-19 The QuickBrace is intended for the immobilization and support of the wrist following fractures, sprains, or surgical procedures.
• 00860014768620 - Mouthflex: 2026-02-19MouthFlex is indicated for rehabilitating jaw and lip mobility in patients suffering from trismus (lockjaw), TMJ disorders, facial burns, or post-radiation fibrosis
• 00860014768620 - Mouthflex: 2026-02-19 MouthFlex is indicated for rehabilitating jaw and lip mobility in patients suffering from trismus (lockjaw), TMJ disorders, faci
• 00860014768613 - LiftWalk: 2026-02-12 A non-AC powered mobile patient lifting system
• 00860014768644 - RideNwalk: 2026-02-12 A non-powered, wheeled mobility aid.
• 00860014768651 - RideNwalk: 2026-02-12 A non-powered, wheeled mobility aid.
• 00860014768668 - LiftWalk: 2026-02-12 Non-AC powered patient lift system.