KneeKG system P-142

GUDID 00627843933236

Emovi Inc

Gait analysis system

• Primary Device ID: 00627843933236
• NIH Device Record Key: 6c0e25be-c6bb-4e18-ab7d-fd1633eb9b6a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: KneeKG system
• Version Model Number: 0
• Catalog Number: P-142
• Company DUNS: 247640605
• Company Name: Emovi Inc
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00627843933236 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K091000

FDA Product Code

• LXJ: Interactive Rehabilitation Exercise Devices

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: 2022-03-31
• Device Publish Date: 2022-03-23

Devices Manufactured by Emovi Inc

• 00627843933236 - KneeKG system: 2022-03-31
• 00627843933236 - KneeKG system: 2022-03-31
• 00627843933243 - KneeKG-Exoskeleton: 2022-03-28