FDA.reportPublic FDA data

TrueStim

Primary DI
00851640007924
Brand
TrueStim
Company
Hi-Dow International Incorporated
Model
HD-08C(TSG-C1)
Device description
Pulsed Electromagnetic Field Wrap,,SHOULDER WRAP Black
Published
2021-01-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
IRTPad, Heating, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ILXDiathermy, Shortwave, For Use Other Than Applying Therapeutic Deep HeatPhysical Medicine2
IRTPad, Heating, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K202337000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202337000Pulsed electromagnetic field wrapHi-Dow International, Inc.2020-12-15ILX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851640007924PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851640007924008516400079248516400079240851640007924

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
124034476
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810093080854PainPodJQ-5C-C2026-10-19
00810093080786PainPod HD-5N-23A2025-12-09
00810093080793PainPod HD-5N-23A2025-12-09
00810093080014PainPodJQ-5C-07A2022-05-16
00851640007573COPPER Fit JQ-5C-07A2020-06-24
00851640007511PainPodJQ-5C-M2020-06-15
00851640007498HiDowJQ-5C-07A 2019-11-21
00851640007504SomacareJQ-5C-C2016-11-02
09351609000023PainPodJQ-5C-B2018-11-02
00851640007009HiDowJQ-5C-E2016-09-01
00851640007016Hi-DowJQ-5C-E2016-09-01
00851640007023HiDowJQ-5C-C2016-09-01
00851640007030HiDowJQ-5C-C2016-09-01
00851640007047HiDowJQ-5C-S2016-09-01
00851640007054HiDowJQ-5C-S2016-09-01
00851640007061HiDowJQ-5C-S2016-09-01
00851640007078HiDowJQ-5C-S2016-09-01
00851640007085HiDowJQ-5C-R2016-09-01
00851640007092HiDowJQ-5C-R2016-09-01
00851640007108HiDowJQ-5C-R2016-09-01

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