FDA.reportPublic FDA data

TrueStim

Primary DI
00081009308007
Brand
TrueStim
Company
Hi-Dow International Incorporated
Model
HD-08B(TSG-E1)
Device description
Pulsed Electromagnetic Field Wrap, Black, lower limb wrap
Published
2023-09-28
Public version status
New
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
00081009308007PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00081009308007000810093080070810093080070081009308007

GMDN Terms#

Term, Definition table
TermDefinition
Short-wave diathermy treatment system, home-useAn assembly of devices designed to be operated by a patient in the home to provide therapeutic deep heat within specific volumes of the body through the transcutaneous transmission of electromagnetic (EM) energy in the radio-frequency bands of 13 megahertz (MHz) to 27.12 MHz. It typically consists of an electric generator and two electrodes (active and return) intended to be held on/near the patient. This system is typically used to treat pain, muscle spasms, and joint contractures; it is not used for surgery or to treat malignancies.

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
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
00851640007115HiDowJQ-5C-R2016-09-01

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Primary DI, Brand, Company table
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00622356704953Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356710664Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356710718Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00622356712200Shark™ DePuffi™SharkNinja Operating LLCIRT2026-06-02
00622356736633Shark FacialPro GlowSharkNinja Operating LLCIRT2026-06-02
00840295411637TherabodyTherabody, Inc.IRT2026-06-01
00041298995043DMID-M-S HOLDINGS, INC.IRT2025-12-30
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00031262109507HomedicsHuizhou XINYI Technology Co., LTDIRT2024-11-12
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00031262115423HomedicsFKA DISTRIBUTING CO., LLCIRT2024-08-30
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00041298991953DMID-M-S HOLDINGS, INC.IRT2024-02-28
B311PETNHTPR0PURE ENRICHMENTBEAR DOWN CONSULTINGIRT2023-12-15
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00031262110541HOMEDICSFKA DISTRIBUTING CO., LLCIRT2023-08-10