Pro-Fit Offloader Left

GUDID 00859718007241

Emsi

Knee support orthosis

• Primary Device ID: 00859718007241
• NIH Device Record Key: 4154bec8-fd25-43f6-9fd1-daf3e68a6379
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Pro-Fit Offloader Left
• Version Model Number: FLEOLK0001 – Offloader left
• Company DUNS: 932471881
• Company Name: Emsi
• 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: false
• 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	00859718007241 [Primary]

FDA Product Code

• ITQ: Joint, Knee, External Brace

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: 2023-03-29
• Device Publish Date: 2023-03-21

Devices Manufactured by Emsi

• 00085971800729 - Hypoallergenic Electrode 2x2 4pk: 2024-08-26
• 00858688006964 - Electrode 45 x 45 16 PK: 2023-09-28
• 00858688006971 - Electrode 1.75 x 1.75 4 pack: 2023-09-28
• 00859718007074 - Electrode 1.75 x 1.75 - 24 PK: 2023-09-28
• 00859718007081 - Electrode 4.0 x 7.0- Dispersive: 2023-09-28
• 00859718007098 - Electrode 1 Inch Round 4 PK: 2023-09-28
• 00859718007104 - Electrode 2" round 4pk: 2023-09-28
• 00859718007111 - Electrode 3 Inch Round 4PK: 2023-09-28