FDA.reportPublic FDA data

PULSE PAD

Primary DI
14897076721501
Brand
PULSE PAD
Company
TENS PLUS INDUSTRIAL COMPANY
Model
Pulse.Pad
Published
2022-11-14
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IMAPack, Heat, Moist

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IMAPack, Heat, MoistPhysical Medicine1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
14897076721501PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
1489707672150114897076721501

GMDN Terms#

Term, Definition table
TermDefinition
Hot/cold therapy pack, reusableA non-sterile device intended to be applied with or without pressure to the body surface (i.e., non-invasively) to provide heat and/or cold therapy for the skin and/or underlying tissues in the treatment of musculoskeletal pain and discomfort (e.g., from sports injuries or rheumatism). It consists of a compact envelope filled with a thermally-retentive material (e.g., silicate-based gel) that can be heated and/or cooled. It may be shaped/sized to fit a specific anatomy or include a strap; it is not intended to support the neck. 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
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
14897076722621Tsubo.VibMY27502023-06-05

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04979844700116NEW MOXA STICKYAMASHO CO.,LTD.IMA2025-02-03
04979844930506MOGUSAN'S MOXA BOXYAMASHO CO.,LTD.IMA2025-02-03
04979844931008DEDICATED CARBONIZED MOXAYAMASHO CO.,LTD.IMA2025-02-03
04979844580015NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
04979844580039NON-SMOKE CHOSEI-KYU MOXAYAMASHO CO.,LTD.IMA2024-06-17
16901452000178Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
06901452000171Hwato Stick-on MoxaSuzhou Medical Appliance FactoryIMA2023-11-15
14897076722454Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
14897076722546Tiger.Warm.STENS PLUS INDUSTRIAL COMPANYIMA2023-06-05
06971175122368sunwin momShanghai Senwo Industry Co., Ltd.IMA2023-05-13
14897076721778Roll.Smoke.LSuzhou Shenlong Medical Apparatus Co., Ltd.IMA2023-04-07
00057475570446BIOS LivingThermor LtdIMA2023-03-31
10057475570443BIOS LivingThermor LtdIMA2023-03-31
08800018916537Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916544GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916551GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
08800018916568Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018914561DBC Moxa BurnerDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916411Tiger Warmer SmallDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916428Tiger Warmer LargeDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916435CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916442GuGwan Burning Bowl 1HoleDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916459GuGwan Burning Bowl 5HolesDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916510"""Moxa Shield """Dong Bang Medical co.,Ltd.IMA2023-01-15
18800018916534Smokeless Mini MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916541GuGwan Moxa SmokelessDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916558GuGwan MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
18800018916565Gold MoxaDong Bang Medical co.,Ltd.IMA2023-01-15
28800018916432CHARCOAL SMOKELESS MOXA CONESDong Bang Medical co.,Ltd.IMA2023-01-15
06971175125567sunwin momShanghai Senwo Industry Co., Ltd.IMA2022-12-30