geko MK1RW02

GUDID 05060294770503

Knee Strap

FIRSTKIND LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 05060294770503
• NIH Device Record Key: d81b883e-beca-40c0-b2f6-4cbd710c70a8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: geko
• Version Model Number: K-1
• Catalog Number: MK1RW02
• Company DUNS: 216603021
• Company Name: FIRSTKIND LTD
• 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: false
• Manufacturing Date: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	05060294770503 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K134001

FDA Product Code

• IPF: Stimulator, Muscle, Powered

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: 2020-11-30
• Device Publish Date: 2020-11-20

On-Brand Devices [geko]

• 05060294771333: geko T-3 pouch with 2 devices
• 05060294770671: geko T-2 US 100 devices per shipper
• 05060294770657: T-2
• 05060294771708: Pack of 5 pouches, each containing 2 geko T-3 devices. Instructions and patient information in e
• 05060294770688: Adhesive accessory A-2
• 05060294770503: Knee Strap
• 05060294771609: W-3