FDA.reportPublic FDA data

POLE ELECTRODE PEN TYPE

Primary DI
14897076721136
Brand
POLE ELECTRODE PEN TYPE
Company
TENS PLUS INDUSTRIAL COMPANY
Model
A4.Pen
Published
2022-11-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
KNMDevice, Pressure Applying

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KNMDevice, Pressure ApplyingPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897076721136PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489707672113614897076721136

GMDN Terms#

Term, Definition table
TermDefinition
External manual massager, clinicalA manual (non-powered) device designed to apply external massage to a patient, by the patient, staff, or a therapist in a hospital, institution, or therapeutic treatment situation. It is intended to stimulate/massage body muscles to provide a therapeutic effect. It is typically designed to be held in the hands and is available in a variety of configurations and materials, e.g., plastic, wood, ceramics. It is available in a variety of sizes and shapes and may be a one-piece device or have interchangeable massaging components (e.g., roller heads or pads), and have a variety of massage surfaces (e.g., points, ribs, smooth). This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
663211978
Device count
1
Premarket exempt
true
Lot or batch
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
14897076721495PULSE PAD LARGE SIZEPulse.Pad.L2022-11-14
14897076721501PULSE PADPulse.Pad2022-11-14
14897076720146GB-3GD5208GD52082021-03-30
14897076723536E-Stim IIIED3981ED39812024-12-10
14897076721457Lion.Warm.XLGY53362023-06-05
14897076721655Multi.D.1.5MD28022023-06-05
14897076721815Moxa.Bx.BamSGY53372023-06-05
14897076721822Moxa.Bx.BamLGY53382023-06-05
14897076721853PistolDY09502023-06-05
14897076721860Pistol.LongDY21112023-06-05
14897076721877Ins.MP.SMD26112023-06-05
14897076721884Ins.MP.MMD26122023-06-05
14897076721891Ins.MP.LMD26132023-06-05
14897076722263Guasha.SBY26082023-06-05
14897076722270Guasha.MBY26092023-06-05
14897076722287Guasha.LBY26102023-06-05
14897076722454Tiger.Warm.SGY53672023-06-05
14897076722546Tiger.Warm.SGY53672023-06-05
14897076722577Bio.N.2MD28632023-06-05
14897076722614Ring.FingerMY26022023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10885632465031HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
20885632465038HalyardOWENS & MINOR DISTRIBUTION, INC.KNM2026-01-22
00818318025352iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
10818318029081iCare Vacuum Cupping SetPrime Holly CorporationKNM2025-05-16
04547248423056SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
04547248423063SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
14547248423053SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
24547248423067SEIRIN PY-ZeroSEIRIN CORPORATIONKNM2025-03-03
06977182810113Shenzhen Wells Optoelectronics Co.,Ltd.Shenzhen Wells Optoelectronics Co.,Ltd.KNM2024-06-16
03760262490625BAT02 Glass rodsSEDATELECKNM2024-04-25
03760262490670EASYO 1 - Multi Pressure FeelerSEDATELECKNM2024-04-25
03760262492902PAL130 Pressure feeler 130gSEDATELECKNM2024-04-25
03760262492919PAL250 Pressure feeler 250gSEDATELECKNM2024-04-25
03760262492926PAL400 Pressure feeler 400gSEDATELECKNM2024-04-25
03760262492933PAL650 Pressure feeler 650gSEDATELECKNM2024-04-25
07350120791955KIWI DermaForeo ABKNM2024-03-11
06901452150005HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150012HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150029HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150050HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150067HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150074HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
06901452150081HWATO Vacuum Cupping SetSuzhou Medical Appliance FactoryKNM2023-11-15
16901452983860HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
36901452983864HWATO Vaccaria seed W/P-50, with TapeSuzhou Medical Appliance FactoryKNM2023-10-10
00840252904004Sensory VestTherafin CorporationKNM2023-07-06
00840252904011Sensory VestTherafin CorporationKNM2023-07-06
00840252904028Sensory VestTherafin CorporationKNM2023-07-06
00840252904035Sensory VestTherafin CorporationKNM2023-07-06
00840252904042Sensory CuffTherafin CorporationKNM2023-07-06