Who else makes this device?

Name: Cascade Iomax
Brand: Cascade Iomax

Cascade Iomax · Electromyograph, Diagnostic → Physical Medicine

2manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Shandong (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code IKN
Manufacturer	City	Province	Registered as	Device types
Shandong Weigao Orthopaedic Device Co., Ltd.	Weihai	Shandong	Contract manufacturer	42
Xian Friendship Medical Electronics Co., Ltd.	Xi’An	Shaanxi	Contract manufacturer	10

Record

Regulatory record for Cascade Iomax
Listed by	Cadwell Industries, Inc., United States
FDA product code	IKN
Device type	Electromyograph, Diagnostic
Device class	Class 2
Regulation	21 CFR 890.1375
Establishment	Specification developer, Manufacturer
510(k)	K162199
Record published	2021-10-15
Record revised	2025-12-30 (version 4)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Label carries	lot or batch number
UDI direct marking	Exempt

Catalogue Numbers

Catalogue numbers for Cascade Iomax
Catalogue number	Size	Status
199306-200		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Electromyograph, Diagnostic	Medtronic Xomed, Inc.	36
Natus	Natus Neurology Incorporated	21
Natus Neurology	Natus Neurology Incorporated	21
NVM5	Nuvasive, Inc.	19
Epad	Safeop Surgical, Inc.	18
Pulse	Nuvasive, Inc.	16
Electromyograph, Diagnostic	Nihon Kohden Corp.	16
Electromyograph, Diagnostic	Nihon Kohden America, Inc.	15
Natus	Xltek	14
Neuropack S3	Nihon Kohden Corp.	8
Electromyograph, Diagnostic	Medtronic Sofamor Danek, Inc.	7
MyoVision Software	Precision Biometrics, Inc.	5

Showing 12 of 49. All products under Electromyograph, Diagnostic

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K162383	2017-03-01

Recalls Naming This Product

2 recalls name this product by its own identifiers, the 510(k) it is cleared under.

Recalls naming the identifiers of Cascade Iomax
Recalled by	Identified by	Initiated	FDA class	Root cause	Reason	Quantity
Cadwell Industries, Inc.	510(k) number	2024-05-17	Class II	Process design	Electroneurodiagnostic medical device may contain a defective printed circuit board which may cause damage to the other internal components resulting in unintended electrical stimulation.	26 units
Cadwell Industries, Inc.	510(k) number	2024-04-23	Class II	Process design	There is the potential that an electroneurodiagnostic medical device insulator may be installed incorrectly which could result in arcing to patient connections resulting in potential unintended shock to the patient.	54 units

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Cascade Iomax