WiTOF

Basic Information

• Brand Name: WiTOF
• Primary DI: 03665023000610
• Version / Model: WiTOF-DEMO
• Company Name: IDMED
• Labeler DUNS: 260233256
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-12-19
• Public Version: 1
• Public Version Date: 2025-12-29
• Public Version Status: New
• Public Device Record Key: 702024e0-d837-4c56-bf5a-e77b87ef7436

Device Description

WiTOF Demonstration kit (WiTOF-MU, power supply, clamp, hand and foot sensors (WiTOFS and WiTOF-FS), user manual, patient simulator)

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: Yes
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: MR Unsafe
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
KOI	Stimulator, Nerve, Peripheral, Electric	Anesthesiology	868.2775	2

GMDN Terms

Code	Name	Definition	Implantable	Status
59693	Neuromuscular transmission lead set	A device(s) intended exclusively to conduct electrical neuromuscular transmission (NMT) signals to/from an array of neuromuscular electrodes attached to the surface of the skin of the hand and forearm, or the foot. The signals are subsequently conducted via a cable to a patient monitoring module to assess the degree of neuromuscular block in a patient. The patient-contact electrodes are not included. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	03665023000610	GS1

Premarket Submissions

Submission Number	Supplement Number
K243339	000