UDI device identifier

Omron Total Power + Heat TENS Unit PM800

UDI device identifier 00073796638009 · Omron Healthcare, Inc.

Key facts

Primary DI 00073796638009
Brand name Omron Total Power + Heat TENS Unit
Version or model PM800
Catalog number PM800
Company Omron Healthcare, Inc.
DUNS number 054318779
Product code NYN
GMDN term Analgesic transcutaneous electrical nerve stimulation system
Premarket submission K181992
Device class Class II
Single use No
Packaged sterile No
Implantable No
Publish date May 6, 2019
Version date Dec 9, 2024
Description Omron TENS Therapy Unit with Heat and 9 preset mode, 2 therapy choices and 20 intensity levels.

At a glance

  • None MAUDE reports citing this UDI
  • Yes Linked premarket submission
  • No EUDAMED counterpart found
  • 10–99 GUDID devices with this product code

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About UDI device identifiers (GUDID)

The Global Unique Device Identification Database (GUDID) holds the device identifiers (UDI-DIs) and key attributes that labelers submit to the FDA for devices that carry a unique device identifier.

Source: U.S. FDA Global Unique Device Identification Database (GUDID), via NLM AccessGUDID · Source date:

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