FDA.reportPublic FDA data

Omron Focus TENS Therapy for Knee -Medium

Primary DI
10073796637139
Brand
Omron Focus TENS Therapy for Knee -Medium
Company
Omron Healthcare, Inc.
Model
PM710-M
Catalog number
PM710-M
Device description
Omron TENS Unit is wearable and wireless, battery operated and includes the device, case, band and pad.
Published
2020-01-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K183215000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K183215000Focus TENS Therapy, Model PM710-M/-LOmron Healthcare, Inc.2019-09-07NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10073796637139PackageGS110In Commercial Distribution
00073796637132PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1007379663713910073796637139
00073796637132000737966371320737966371320073796637132

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature32 Degrees Fahrenheit104 Degrees Fahrenheit

Sterilization Methods#

Method table
Method

Contacts#

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

Regulatory Flags#

DUNS number
054318779
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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00073796146054AC Adapter for digital Blood Pressure UnitsHEM-ADPTW5HEM-ADPTW52016-09-16
00073796149079AC Adapter for HEM-907XLHEM-ADPT907HEM-ADPT9072016-09-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNYN2026-05-27
06977159460037GYMMAXGymmax Technology (Shenzhen) Co., Ltd.NYN2026-04-24
06976287180336Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180343Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
06976287180350Portable Electro Stimulation Therapy DeviceGuangzhou Longest Medical Technology Co., Ltd.NYN2026-04-02
04719872263029Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
04719872264132Well-LifeWELL-LIFE HEALTHCARE LTD.NYN2026-03-30
06971712720125ProcomfortHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-12-10
00810140062697RENPHOJoicom CorporationNYN2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NYN2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NYN2025-10-03
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NYN2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NYN2025-09-11
00810113683379DualPulse CompactManamed, Inc.NYN2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NYN2025-09-11
06971712720057NEOCARBONHong Qiangxing (Shen Zhen) Electronics LimitedNYN2025-08-31
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NYN2025-08-21
03770018808239actiTENSSUBLIMEDNYN2025-02-07
00092237626870TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
00092237626856TENS 7000Drive Devilbiss HealthcareNYN2025-01-06
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