N/A

GUDID 50092237615220

InTENSity EX4 Professional

COMPASS HEALTH BRANDS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID50092237615220
NIH Device Record Keyc9b23558-4282-44b1-94da-d4d4a0e6293e
Commercial Distribution StatusIn Commercial Distribution
Brand NameN/A
Version Model NumberDQ7000
Company DUNS827221698
Company NameCOMPASS HEALTH BRANDS CORP.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone440-572-1962
EmailCustomerService@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100092237615225 [Primary]
GS150092237615220 [Package]
Contains: 00092237615225
Package: CA [2 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-10-23
Device Publish Date2016-10-12

On-Brand Devices [N/A]

01815067013134Viverity Pain Relief Pad,
80813520013025Snaps-Black with Pigtail
80092237616020Electrode - Relief Wrap - 2x2
01813520011918Electrode - Poly - 1.5x14 -
01813520011895Electrode - Foil - 2x4 - White
01813520011888Electrode - Foil - 2x4 - Tan
80081352001156TENS AA - Digital TENS Unit
80813520011335Electrode - Poly - 2x3.5 -
01813520011314Self-Adhering Electrodes, 2
01813520010492Electrode - Foil - 2x3.5 -
30813520010364Electrode - Poly - 3 - White
01813520010355Electrode - Poly - 2x3.5 -
00813520010332Electrode - Poly - 1.5x1.5 -
01813520010249Lead Wire - Standard 45
80813520010147Electrodes, Foil Bag, 2.0 x
80813520010130Electrode - Foil - 2x3.5 - Tan
80813520010116Electrode, 4 x 6 Butterfly
01813520010058Electrode - Foil - 2 - White
01813520010034Electrode - Foil - 2x2 - White
80092237619137Electrode - 2x2 - Tan Cloth
010922376183313 Round - Red Rubber
800922376183212 " round red rubber electrodes
010922376183172 " round black rubber electrodes
01092237617495Church Key Lead Wire style
80092237617478UltraTENS II Leadwire - Single
80092237617461TOP TENS White Lead Wires
800922376174545 Foot Lead Wire(2 per pkg)
80092237617447IF 4K Lead Wires, one pair
01092237617433Mini TENS Lead Wire w/ Snaps
80092237617423Mini TENS Lead Wire for Pin
01092237617419Lead Wire Extender
00092233761742Combination Lead Wire for
80092237617393Combination Lead Wire for
00092237617335Quattro Lead Wires - 10 Foot
80092237617195Rubber Electrodes, 2.75 x
01092237617181Rubber Electrodes, 2.5 x 3.5
01092237617174MiniElectrode - for mini-TENS
80092237617164Electrode - 4 - Red Rubber
01092237617150Electrode - 4 - Black Rubber
800922376171403 Round - Black Rubber
01092237617136InTENSity Tan Cloth 2 x 2
30092237617107Premium Silver Electrodes, 2
30092237617091Hypoallergenic Electrodes,
80092237617072Electrode - 1.5x2.5 - White
00092237617007Electrode - Foil - 3 - White
80092237616990Electrode - Foil - 3 - White
800922376169763 Round Electrode, Foil
010922376169482 x 2 Sterile Electrode, 4 per
00092237616888Electrode - Foil - 1.5x3.5 -
80092237616877Electrode - Sterile Foil - 1.5x3 -

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.