FDA.reportPublic FDA data

Omron Electrotherapy Pain Relief Long Life Pads

Primary DI
00073796614324
Brand
Omron Electrotherapy Pain Relief Long Life Pads
Company
Omron Healthcare, Inc.
Model
PMLLPADCAN-L
Catalog number
PMLLPADCAN-L
Device description
Electrotherapy Pain Relief Long Life Pads
Published
2017-05-17
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120516000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120516000LONG LIFE PADTMOmron Healthcare, Inc.2012-05-17GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796614321PackageGS16In Commercial Distribution
20073796614328PackageGS12In Commercial Distribution
00073796614324PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379661432110073796614321
2007379661432820073796614328
00073796614324000737966143240737966143240073796614324

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-800-634-4350quality@omron.com

Regulatory Flags#

DUNS number
054318779
Device count
1
Lot or batch
true
Expiration date on label
true

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Primary DI, Brand, Company table
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