Analgesic

GUDID 80092237614675

InTENsity 10 (Analgesic) w/o

COMPASS HEALTH BRANDS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID80092237614675
NIH Device Record Keye941541c-e91b-4b87-b3c4-74a2805252f1
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnalgesic
Version Model NumberDI1019-2
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 Kittrue
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
GS100092237614679 [Primary]
GS180092237614675 [Package]
Contains: 00092237614679
Package: CA [32 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 Number5
Public Version Date2019-10-23
Device Publish Date2016-10-12

On-Brand Devices [Analgesic]

80092237619168Butterfly Electrode
01092237619147Electrode - 2.75x5 - Tan
80092237619120Electrode - 1.5x1.5
01092237619116Electrode - 1.2 - Tan Cloth
80092237618949Elect - Poly - 2x2 - Tan Cloth
80092237618840TENS 7000 (Analgesic)
80092237618734TENS 3000 (Analgesic)
80092237618635Twin Stim 2nd (Analgesic)
01092237616856E1P1515TC2A
80092237614675InTENsity 10 (Analgesic) w/o

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