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TruWave TENS

FDA UDI

Class II (US FDA UDI)

by Zynex Medical, Inc.

Identity

Trade Name
TruWave TENS FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation FDA UDI
Model / Reference
400420 FDA UDI
Description
An electrotherapy device which provides symptomatic pain relief with Transcutaneous Electrical Nerve Stimulation FDA UDI

Identifiers

Primary DI / UDI-DI
00852670007021 FDA UDI
510(k) Number
K013210 FDA UDI
FDA Product Code
GZJ FDA UDI
GMDN Term
Analgesic transcutaneous electrical nerve stimulation system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
882.5890 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

Yes

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

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

TruWave TENS by Zynex Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Zynex Medical, Inc.

Sources (1)

  • FDA UDI c54db598-88f7-4a20-80f4-83edd19a2afb 35 fields · synced May 31, 2026