CADWELL INDUSTRIES, INC.

Registration Details

Registration Name: CADWELL INDUSTRIES, INC.
Registration Number: 3020018
FEI Number: 3020018
Status: Active
Expiry Year: 2026
Initial Importer: Yes
Address: 909 N Kellogg St
City: KENNEWICK
State: WA
ZIP: 99336
Country: US

Regulatory Submissions

510(k) Number: K180269

Owner / Operator

Firm Name: CADWELL INDUSTRIES, INC.
Operator Number: 3020018
Address: 909 NORTH KELLOGG ST., --
City: Kennewick
State: WA
Postal Code: 99336
Country: US
Correspondent: Becky Corral

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Standard Polysomnograph With Electroencephalograph	OLV	Class 2	Neurology	No	2018-07-23
Reduced- Montage Standard Electroencephalograph	OMC	Class 2	Neurology	No	2018-07-23
Stimulator, Photic, Evoked Response	GWE	Class 2	Neurology	No	2018-07-23
Non-Normalizing Quantitative Electroencephalograph Software	OLT	Class 2	Neurology	No	2018-07-23
Amplifier, Physiological Signal	GWL	Class 2	Neurology	No	2018-07-23
Full-Montage Standard Electroencephalograph	GWQ	Class 2	Neurology	No	2018-07-23
Device, Sleep Assessment	LEL	Class 2	Neurology	No	2007-12-11
Ventilatory Effort Recorder	MNR	Class 2	Anesthesiology	No	2007-12-11
Oximeter	DQA	Class 2	Cardiovascular	No	2007-12-05
Tape And Bandage, Adhesive	KGX	Class 1	General Hospital	No	2023-01-20
Stimulator, Nerve	ETN	Class 2	Ear, Nose, Throat	No	2018-09-13
Electrode, Cortical	GYC	Class 2	Neurology	No	2018-09-13
Stimulator, Electrical, Evoked Response	GWF	Class 2	Neurology	No	2018-09-13
System, Communication, Powered	ILQ	Class 2	Physical Medicine	No	2016-07-08
Stimulator, Auditory, Evoked Response	GWJ	Class 2	Neurology	No	2017-03-10
Device, Galvanic Skin Response Measurement	GZO	Class 2	Neurology	No	2017-03-10
Device, Nerve Conduction Velocity Measurement	JXE	Class 2	Neurology	No	2017-03-10
Electromyograph, Diagnostic	IKN	Class 2	Physical Medicine	No	2017-03-10
Monitor, Breathing Frequency	BZQ	Class 2	Anesthesiology	No	2021-05-14
Electrode, Cutaneous	GXY	Class 2	Neurology	No	2007-12-11
Interactive Rehabilitation Exercise Devices	LXJ	Class 2	Physical Medicine	No	2021-10-21
Cable, Electrode	IKD	Class 2	Physical Medicine	No	1994-02-25
Neurosurgical Nerve Locator	PDQ	Class 2	Ear, Nose, Throat	No	2024-01-02
Stimulator, Mechanical, Evoked Response	GZP	Class 2	Neurology	No	2017-03-10

Proprietary Names

EasyNet Limb Movement Module ApneaTrak EasyNet Oximeter Module EasyNet Body Position Module Sleepmate Oximetry Tape Patient Event Switch Cascade IOMAX Cascade Surgical Studio SW CannuTherm; Sleepmate Airflow Sensor EEG Gold Cup Electrode Disposable Tab Electrodes Cadwell Disposable Concentric Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Flush Tip Direct Nerve Stimulator Probes - various lenghts Cadwell Disposable Double Ball Tip Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Bipolar Direct Nerve Stimulator Probes - various lengths Cadwell Disposable Detachable Mono-polar Probe - various lengths Cadwell Disposable Ball Tip Bent Stimulator Probes - various lenghts Cadwell Disposable Ball Tip Direct nerve Stimulator Probes - various lenghts Cadwell Disposable Double Hook Nerve Stimulator Probes - various lengths and angles Cadwell Disposable Triple Hook Nerve Stimulator Probes - various lengths and angles Cadwell Disposable Mono-polar Direct Nerve Stimulator Probes - various lengths Cadwell Detachable Ball Tip Probe Shaft - various lengths Sleepmate Body Position Sensor Probe Extension Cable Disposable Clip-on Leadwire Shielded Interconnect Cable Reference Jumper Mini-Crocodile Clip Lead Wires Extender Pods Disposable Multistage Leadwire Ring Electrodes Bluebird Respiratory Effort Belt RIPmate; Sleepmate Respiratory Effort Sensor Bar Electrodes Arc Essentia Arc Alterna Arc Synopsis Software Disc Electrodes Easy Ambulatory2 EEG Recorder, Easy Ambulatory EEG Recorder, Easy Wireless EEG Recorder Easy ApneaTrak Recorder Easy Ambulatory2 PSG Recorder Sleepmate Snore Sensor Ground Plate Electrode Easy III EEG/PSG Cascade Pro IOM Sierra Summit EasyNet Nasal Pressure Module

Establishment Types

Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility