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Omron Heat Pain Pro

FDA UDI

Class II (US FDA UDI)

by Omron Healthcare, Inc.

Identity

Trade Name
Omron Heat Pain Pro FDA UDI
Generic Name
Analgesic transcutaneous electrical nerve stimulation system FDA UDI
Device Name
Electrotherapy Heat Pain Pro TENS Unit FDA UDI
Model / Reference
PM311 FDA UDI
Description
Electrotherapy Heat Pain Pro TENS Unit FDA UDI

Identifiers

Catalog Number
PM311 FDA UDI
Primary DI / UDI-DI
00073796633110 FDA UDI
510(k) Number
K160115 FDA UDI
FDA Product Code
NUH 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

No

FDA UDI

Over-the-Counter

Yes

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

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation system

Omron Heat Pain Pro by Omron Healthcare, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Analgesic transcutaneous electrical nerve stimulation system.

Cleared under the same submission

K160115 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Omron Healthcare, Inc.

Sources (1)

  • FDA UDI 33af2159-f1df-49a9-9e79-b7cc68127834 37 fields · synced May 30, 2026