FDA.reportPublic FDA data

N/A

Primary DI
80092237616792
Brand
N/A
Company
COMPASS HEALTH BRANDS CORP.
Model
DT7202
Device description
TENS 7000 Digital
Published
2016-10-12
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237616792PackageGS132In Commercial Distribution
00092237616796PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761679280092237616792
00092237616796000922376167960922376167960092237616796

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. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00092237613269Roscoe MedicalLS52662016-10-13
00194346678921Equate73085EQ2026-03-09
00714905117649Fab StimDT30252026-02-06
00714905710024Fab StimDT70252026-02-06
00860163000312CMS DT30292026-02-06
00092237622209SCRIPHESSCO672-0192-CH2026-02-03
00092237622216SCRIPHESSCO672-0193-CH2026-02-03
00092237622339SCRIPHESSCO672-0195-CH2026-02-03
30194346615156Equate 72085EQ2026-01-20
00092237627495Roscoe MedicalO2C6P2026-01-15
00023601130402CarexFGB30400 00002025-12-01
00092237622193SCRIPHESSCO672-0010-CH2025-11-24
00714905710062FabStimE1P3000TC2FS2025-11-18
00092237621967TwinStimDS5002-OTC2025-09-29
00092237902257MicroBlock Antimicrobial Electrode400-877-MIC2020-06-11
00092237902240MicroBlock Antimicrobial Electrode400-872-MIC2019-01-08
00092237902288MicroBlock Antimicrobial Electrode400-852-MIC2020-06-11
00092237902264MicroBlock Antimicrobial Electrode400-879-MIC2020-06-11
00092237902271MicroBlock Antimicrobial Electrode400-881-MIC2020-06-11
00092237611531Roscoe MedicalLS52552016-10-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06971712727704YUN MANSIONHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-26
00850080988466AUVONUAN HEALTHCARE LIMITEDNUH2026-05-24
06932307410418JIAJIANWuxi Jiajian Medical Instrument Co.,Ltd.NUH2026-03-04
00714905710024Fab StimCOMPASS HEALTH BRANDS CORP.NUH2026-02-06
06971292004301AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2026-01-21
00850016867407Pixie CupPixie Cup LLCNUH2026-01-09
06971292004295AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-12-17
00810093080786PainPod Hi-Dow International IncorporatedNUH2025-12-09
00810093080793PainPod Hi-Dow International IncorporatedNUH2025-12-09
04719871185605iSTIMEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
04719871186039EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.NUH2025-12-03
16978452680020EPULSEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
16978452680037KONGZEEShenzhen Jiantuo Electronics Co., LtdNUH2025-12-01
06971292004127AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-22
10850073128180AVCOOADP HEALTH LIMITEDNUH2025-09-19
10850073128197AVCOOADP HEALTH LIMITEDNUH2025-09-19
16971292004117AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-19
10850073128166AVCOOADP HEALTH LIMITEDNUH2025-09-18
06971292004103AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-11
16971292008078AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-09-02
16970890320681AUVONShenzhen As-Tec Technology Co.,Ltd.NUH2025-08-30
00850073128121AVCOOADP HEALTH LIMITEDNUH2025-08-25
10850073128135AVCOOADP HEALTH LIMITEDNUH2025-08-25
06973602730719reajoyTOP-RANK HEALTH CARE CO., LTD.NUH2025-08-21
16978452680013NURSALShenzhen Jiantuo Electronics Co., LtdNUH2025-08-21
06971292008064AUVONShenzhen Yuwen E-Commerce Co., Ltd.NUH2025-08-12
16971712724717UnimedHong Qiangxing (Shen Zhen) Electronics LimitedNUH2025-08-11
00851221006803Quell 2.0NEUROMETRIX, INC.NUH2025-08-01
16978146200107SinrelSHENZHEN SINREL TECH LTDNUH2025-07-14
04251784906101HealyHealy GmbHNUH2025-07-10