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IOMAX Extender Pod

FDA UDI

Class II (US FDA UDI)

by Cadwell Industries, Inc.

Identity

Trade Name
IOMAX Extender Pod FDA UDI
Generic Name
Electromyograph FDA UDI
Device Name
TCS-9 Output Extender FDA UDI
Model / Reference
362068-000 FDA UDI
Description
TCS-9 Output Extender FDA UDI

Identifiers

Primary DI / UDI-DI
00840067102657 FDA UDI
510(k) Number
K162199 FDA UDI
FDA Product Code
GWE FDA UDI
GWQ FDA UDI
IKN FDA UDI
OLT FDA UDI
GWF FDA UDI
ETN FDA UDI
GWJ FDA UDI
DQA FDA UDI
GZO FDA UDI
JXE FDA UDI
GMDN Term
Electromyograph FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.1890 FDA UDI
882.1400 FDA UDI
890.1375 FDA UDI
882.1870 FDA UDI
874.1820 FDA UDI
882.1900 FDA UDI
870.2700 FDA UDI
882.1540 FDA UDI
882.1550 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Electromyograph

IOMAX Extender Pod by Cadwell Industries, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Electromyograph.

Cleared under the same submission

K162199 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Cadwell Industries, Inc.

Sources (1)

  • FDA UDI 12711f17-c695-40ac-a3ae-ebede1ce8e37 35 fields · synced Jun 9, 2026