FDA.reportPublic FDA data

DR -HOS

Primary DI
06970742221787
Brand
DR -HOS
Company
Guangzhou Xinbo Electronic Co., Ltd.
Model
DH-P.T.S-I
Device description
DR-HO'S Circulation Promoter XP TENS
Published
2022-01-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Product Codes#

Code, Name table
CodeName
NGXStimulator, Muscle, Powered, For Muscle Conditioning

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K212948000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K212948000Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)Guangzhou Xinbo Electronic Co., Ltd.2021-11-01NGX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06970742221787PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06970742221787069707422217876970742221787

GMDN Terms#

Term, Definition table
TermDefinition
Physical therapy transcutaneous neuromuscular electrical stimulation systemAn electrically-powered unit intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
530683813
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
06970742220339DR-HOSMotionciser2025-06-30
06970742220278DR-HOSDHP-King2023-11-12
06970742220285DR-HOSDHP-Queen2023-11-12
06970742220292DR-HOSDHP-Children2023-11-12
06970742220308DR-HOSDHP-Travel2023-11-12
06970742220315DR-HOSDHP-Leg2023-11-12
06970742221770DR -HOSDH-CP-I2022-01-07
06970742221794DR -HOSDH-P.T.S-II2022-01-07
06970742221800DR -HOSDH-P.T.S-IIA2022-01-07
06970742221817DR -HOSDH-P.T.S-IIB2022-01-07
06970742221824DR -HOSP.T.S-III2022-01-07
06970742221411DR-HO'SCP-I2020-03-01
06970742221428Equate P.T.S-II2020-03-01
06970742221435DR-HO'SP.T.S- II B2020-03-01
06970742221442DR-HO'SP.T.S-II A2020-03-01
06970742221459DR-HO'SP.T.S-II2020-03-01
06970742221732DR -HOSNN-KN-Blue2021-09-01
06970742221725DR -HOSNN-CA-Blue2021-09-01
06970742221749DR -HOSNN-AN-Blue2021-09-01
06970742221473DR-HO'SPBR-12020-03-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
00199874125305Muscle StimulatorShenzhen Yiran Intelligence Co., Ltd.NGX2026-05-08
00850051584048Neuro20 PRO SystemNEURO20 TECHNOLOGIES CORP.NGX2026-05-05
00810060832851Venus NovaVenus Concept Inc.NGX2026-04-15
00810093080786PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNGX2025-12-09
00810140062680RENPHOJoicom CorporationNGX2025-10-20
00810140062697RENPHOJoicom CorporationNGX2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NGX2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NGX2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNGX2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNGX2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNGX2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NGX2025-09-11
00850073128138AVCOOADP HEALTH LIMITEDNGX2025-08-25
00850073128121AVCOOADP HEALTH LIMITEDNGX2025-08-25
00810113683232ManaFlexx 2 Electrodes - 10 packManamed, Inc.NGX2025-08-21
00092237621974TwinStimDrive Devilbiss HealthcareNGX2025-08-15
08885022060018Quantum Mitohormesis (QMT)QUANTUMTX PTE. LTD.NGX2025-07-21
00850073128107AVCOOADP HEALTH LIMITEDNGX2025-07-02
00194346469680EQUATEWAL-MART STORES, INC.NGX2025-06-13
00850073128091AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128084AVCOOADP HEALTH LIMITEDNGX2025-05-26
00850073128046AVCOOADP HEALTH LIMITEDNGX2025-04-03