FDA.reportPublic FDA data

FifthPulse

Primary DI
00810084936887
Brand
FifthPulse
Company
Jeg & Sons Inc.
Model
5 Pack
Catalog number
FMN100525
Device description
Instant Cold Pack
Published
2022-12-16
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true
Single use
true

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
00810084936887PrimaryGS10
00810084938355Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00810084936887008100849368878100849368870810084936887
00810084938355008100849383558100849383550810084938355

GMDN Terms#

Term, Definition table
TermDefinition
Musculoskeletal hot/cold therapy pack, single-useA non-powered 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, nor is it designed to be dedicated to eye thermal therapy. This is a single-use device.

Regulatory Flags#

DUNS number
789973646
Device count
5
Premarket exempt
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810084936894FifthPulse10 PackFMN1005262022-12-16
00810084938355FifthPulse10 PackFMN1005262022-12-16
00810084936900FifthPulse10 PackFMN1005272022-12-16
00810084936917FifthPulse20 PackFMN1005282022-12-16
00810084938362FifthPulse20 PackFMN1005282022-12-16
00850026094305FifthPulseFP050-TS2021-07-01
00850026094312FifthPulseFP050-L2021-07-01
00850028714492FifthPulseFP100-TS2021-07-01
00850028714508FifthPulseFP100-L2021-07-01
00850026094299FifthPulseFP607-G2021-07-01
00850028714614FifthPulseFP607-GK2021-07-01
00683346554989WeCare3-Ply BlueWMN1000042022-12-16
00683346554996WeCare3-Ply BlueWMN1000052022-12-16
00810084932087WeCareNavy - AdultsWMN1001412022-12-16
00810084932094WeCareDark Gray - AdultsWMN1001422022-12-16
00810084932810WeCareOcean Tones - AdultsWMN1001232022-12-16
00810084932827WeCareEarth Tones - AdultsWMN1001262022-12-16
00810084932834WeCareAssorted Tie Dye - AdultsWMN1001272022-12-16
00810084939307WeCareNavy - AdultsWMN1001412022-12-16
00810084939314WeCareDark Gray - AdultsWMN1001422022-12-16

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