FELIX

GUDID 00850077317040

Strap Grey S1

Fasikl Incorporated

Tremor-suppression transcutaneous electrical stimulation wristband

• Primary Device ID: 00850077317040
• NIH Device Record Key: e2c8f5db-60f7-4303-ae4a-f9d08dff24f0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FELIX
• Version Model Number: S1
• Company DUNS: 103758013
• Company Name: Fasikl Incorporated
• 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: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850077317040 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K250096

FDA Product Code

• QBC: External Upper Limb Tremor Stimulator

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: 2025-08-21
• Device Publish Date: 2025-08-13

On-Brand Devices [FELIX]

• 00850077317262: Stimulator grey FELIX-G1
• 00850077317255: Stimulator blue FELIX-G1
• 00850077317248: Stimulator purple FELIX-G1
• 00850077317231: Stimulator pink FELIX-G1
• 00850077317224: CB1-S1
• 00850077317217: CB1-M1
• 00850077317200: CB1-M2
• 00850077317194: CB1-M3
• 00850077317187: CB1-L1
• 00850077317170: CB1-L2
• 00850077317163: Electrode Band black EB1-S1
• 00850077317156: Electrode Band black EB1-M1
• 00850077317149: Electrode Band blackEB1-M2
• 00850077317132: Electrode Band black EB1-M3
• 00850077317125: Electrode Band black
• 00850077317118: Electrode Band black EB1-L2
• 00850077317040: Strap Grey S1
• 00850077317033: Strap blue S1
• 00850077317026: Strap pink S1
• 00850077317019: Strap purple S1
• 00850077317002: C1