FDA.reportPublic FDA data

WiTOF

Primary DI
03665023000573
Brand
WiTOF
Company
IDMED
Model
WiTOF-FS
Device description
Foot sensor and electrodes connector
Published
2025-12-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true

Product Codes#

Code, Name table
CodeName
KOIStimulator, Nerve, Peripheral, Electric

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KOIStimulator, Nerve, Peripheral, ElectricAnesthesiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K243339000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K243339000WiTOFIdmed2025-06-23KOI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03665023000573PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03665023000573036650230005733665023000573

GMDN Terms#

Term, Definition table
TermDefinition
Neuromuscular transmission lead setA 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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
260233256
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03665023001112CuffGuardCG-TUB12025-12-19
03665023000535WiTOFWiTOF-MUWiTOF-MU2025-12-19
03665023000542WiTOFWiTOF-MU2025-12-19
03665023000559WiTOFWiTOF-S2025-12-19
03665023000566WiTOFWiTOF2025-12-19
03665023000610WiTOFWiTOF-DEMO2025-12-19
03665023000948CuffGuardCG-MU_ID2025-12-19
03665023000955CuffGuardCG-MU_DR2025-12-19
03665023000962CuffGuardPWR5-U_EU2025-12-19
03665023000979CuffGuardPWR5-U_UK2025-12-19
03665023000986CuffGuardPWR5-U_US2025-12-19
03665023000993CuffGuardPWR5-U_TI2025-12-19
03665023001020CuffGuardCG-KIT_ID2025-12-19
03665023001068CuffGuardCG-TUB12025-12-19
03665023002515CuffGuardPWR5-U_TI2025-12-19
03665023002522CuffGuardPWR5-U_EU2025-12-19
03665023002539CuffGuardPWR5-U_UK2025-12-19
03665023002546CuffGuardPWR5-U_US2025-12-19
03665023000030TOF-MUTOF-MUTOF-MU2018-07-13
03665023000122TOF-CHAR_USTOF-CHAR_USTOF-CHAR_US2018-07-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKOI2026-04-15
03665023000535WiTOFIDMEDKOI2025-12-19
03665023000542WiTOFIDMEDKOI2025-12-19
03665023000559WiTOFIDMEDKOI2025-12-19
03665023000566WiTOFIDMEDKOI2025-12-19
03665023000610WiTOFIDMEDKOI2025-12-19
04255629200751Mechanomyography Sensor (MMG) for Neuromuscular Transmission Monitor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2025-11-21
00860012119660iTOFNERBIO PRIVATE LIMITEDKOI2025-02-05
00850023319005TwitchView Medium ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319029TwitchView™BLINK DEVICE COMPANYKOI2024-11-07
00850023319036TwitchView Small ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
00850023319098TwitchView2 MonitorBLINK DEVICE COMPANYKOI2024-11-07
00850023319104TwitchView2 Charging DockBLINK DEVICE COMPANYKOI2024-11-07
00850023319111TwitchView2 Patient Cable 14'BLINK DEVICE COMPANYKOI2024-11-07
00850023319173TwitchView2 Patient Cable 20'BLINK DEVICE COMPANYKOI2024-11-07
00850023319180TwitchView Large ElectrodeBLINK DEVICE COMPANYKOI2024-11-07
07350012440268TetraHubSenzime AB (Publ.)KOI2024-10-11
07350012440237TetraGraphSenzime AB (Publ.)KOI2024-10-03
07350012440169TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440183TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440244TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440176TetraSensSenzime AB (Publ.)KOI2024-04-26
07350012440190TetraSens PediatricSenzime AB (Publ.)KOI2024-04-26
07350012440251TetraSensitiveSenzime AB (Publ.)KOI2024-04-26
07350012440206TetraSensitiveSenzime AB (Publ.)KOI2023-11-06
04255629200904EPSIMEDEPSIMED LLCKOI2023-10-25
04255629200423Eye adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200454Thumb adapter TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200393TOF3D - Neuromuscular Transmission MonitorMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10
04255629200409Temperature sensor TOF3DMIPM Mammendorfer Institut für Physik und Medizin GmbHKOI2023-07-10