FDA.reportPublic FDA data

InTENSity 7

Primary DI
80092237623431
Brand
InTENSity 7
Company
COMPASS HEALTH BRANDS CORP.
Model
DI0007
Device description
InTENSity 7 Digital TENS Device with Accessories
Published
2022-06-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Safe
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
80092237623431PackageGS132In Commercial Distribution
00092237623435PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223762343180092237623431
00092237623435000922376234350922376234350092237623435

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

Contacts#

Phone, Email table
PhoneEmail
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
827221698
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
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
30194346615156Equate 72085EQ2026-01-20
40076855700608Apex70060BPKG2025-08-28
30023601200519AccuReliefACRL-00512025-07-17
30092237628561TENS 7000DT7308-ELEC42025-07-10
30092237628554TENS 7000DT7307-ELEC82025-06-30
30023601088209CarexFGE82000 00002025-06-25
30627394040019Pain CakesTMF70001CA2025-06-03
30627394040057Pain CakesTMF70005CA2025-06-03
30627394040064Pain CakesTMF70006CA2025-06-03
30023601017100CAREX HEALTH BRANDSFGA71000 00002025-05-21
30627394023036CarexFGB303CA2025-05-13
50023601023037CarexFGB30300 00002025-02-19
80092237626845TENS 7000DT73152025-01-21
30092237626734TENS 7000DT73092025-01-06
30092237626741TENS 7000DT73102025-01-06
30092237626758TENS 7000DT73142025-01-06
30632615880107Bed BuddyBBF8010-122024-12-18
30023601261008AccuReliefACRL-52002024-12-17
30041520865817Apex70010AHO2024-12-09
30635515992765Apex70010QC2024-12-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27
00850080988435AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988442AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988459AUVONUAN HEALTHCARE LIMITEDNUH2026-05-21
00850080988411AUVONUAN HEALTHCARE LIMITEDNUH2026-05-06
00194346404155EquateWAL-MART STORES, INC.NUH2026-05-01
00850080988381AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988398AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850080988404AUVONUAN HEALTHCARE LIMITEDNUH2026-04-29
00850044118762iHealthiHealth Labs Inc.NUH2026-04-16
00850080988145AUVONUAN HEALTHCARE LIMITEDNUH2026-03-23
00850080988138AUVONUAN HEALTHCARE LIMITEDNUH2026-03-19
00850016867209Pixie CupPixie Cup LLCNUH2025-11-05
00810140062680RENPHOJoicom CorporationNUH2025-10-20
00810140062697RENPHOJoicom CorporationNUH2025-10-20
00810113683782ManaRecovery Stimulation System Manamed, Inc.NUH2025-10-03
00810113683799ManaRecovery Stimulation System Electrode PadManamed, Inc.NUH2025-10-03
00092237621967TwinStimDrive Devilbiss HealthcareNUH2025-09-29
00850073128183AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128190AVCOOADP HEALTH LIMITEDNUH2025-09-19
00850073128169AVCOOADP HEALTH LIMITEDNUH2025-09-18
00810113683485ManaFlexx 2 Electrodes - 4 electrodesManamed, Inc.NUH2025-09-11
00810113683225ManaFlexx 2 Lead WiresManamed, Inc.NUH2025-09-11
00810113683379DualPulse CompactManamed, Inc.NUH2025-09-11
00810113683386DualPulse Compact Replacement Gel PadManamed, Inc.NUH2025-09-11