Model PM3030: FDA 510(k) K110068, Omron Healthcare, Inc.

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK110068	Date8 Dec 2011Cleared	StatusActive

Official records

FDA 510(k) database 510(k) number K110068

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number: K110068
FDA product code: NUH

Device class: Class II
Regulation: 21 CFR Part 882.5890
Advisory committee: Neurology
FDA decision: SESE Substantially Equivalent

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Therapeutic Massage Companion K060846 3 Dec 2007 FDA record

Cited by

5000Z Firefly System K133502 3 Dec 2014 FDA record · FDA summary
Maxpower Relief K141978 3 Dec 2014 FDA record · FDA summary
Easystim TN28_OTC K140168 28 Aug 2014 FDA record · FDA summary
Counter Otc Tens Device K132993 24 Apr 2014 FDA record · FDA summary
Tanyx K123866 13 Sep 2013 FDA record · FDA summary
The Pain Pilot (A.K.A Pain Pilot) K120500 20 Aug 2012 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K110068

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K110068
		UDI-DI	Size and differences
Omron Electrotherapy Pain Relief PM3030 Omron Healthcare, Inc.	PM3030 / PM3030	00073796633035	—	On the market
Omron Pain Relief Pro PM3031 Omron Healthcare, Inc.	PM3031 / PM3031	00073796330316	—	No longer on the market
Omron Pain Relief Pro PM3031CAN Omron Healthcare, Inc.	PM3031CAN / PM3031CAN	00073796633141	—	No longer on the market

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

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Regulatory status

Coverage

Specification

Related clearances

Cites

Cited by

Devices cleared under K110068

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