firefly SK1RW02

GUDID 05060294770107

Knee Strap

FIRSTKIND LTD

Physical therapy transcutaneous neuromuscular electrical stimulation system

• Primary Device ID: 05060294770107
• NIH Device Record Key: 20b433cd-0b95-4c5a-8ab0-f161973de51b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: firefly
• Version Model Number: K-1
• Catalog Number: SK1RW02
• 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	05060294770107 [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 [firefly]

• 05060294770459: T-1
• 05060294771654: firefly T-2 carton of 25 pouches, each containing 2x firefly devices
• 05060294770107: Knee Strap