CMS

GUDID 00860163000312

TENS 3000 CMS

COMPASS HEALTH BRANDS CORP.

Physical therapy transcutaneous neuromuscular electrical stimulation system
Primary Device ID00860163000312
NIH Device Record Keye734344e-32fd-4b2e-93ae-5bebf55f7174
Commercial Distribution StatusIn Commercial Distribution
Brand NameCMS
Version Model NumberDT3029
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

Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com
Phone800-376-7263
Emailcustomerservice@compasshealthbrands.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860163000312 [Primary]

FDA Product Code

GZJStimulator, Nerve, Transcutaneous, For Pain Relief

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-16
Device Publish Date2026-02-06

Devices Manufactured by COMPASS HEALTH BRANDS CORP.

00092237613269 - Roscoe Medical2026-03-17 TheraSonic Conductive Gel, 16oz LS5266CA
00194346678921 - Equate2026-03-17
00714905117649 - Fab Stim2026-02-16 Fab Stim Analog TENS
00714905710024 - Fab Stim2026-02-16 Fab Stim Plus - Digital TENS
00860163000312 - CMS 2026-02-16TENS 3000 CMS
00860163000312 - CMS 2026-02-16 TENS 3000 CMS
00092237622209 - SCRIPHESSCO2026-02-11 SCRIPHESSCO BASIC ELECTRODE 2" ROUND CLOTH, 4/PK
00092237622216 - SCRIPHESSCO2026-02-11 SCRIPHESSCO BASIC ELECTRODE 2" X 2" CLOTH, 4/PK
00092237622339 - SCRIPHESSCO2026-02-11 SCRIPHESSCO PREMIUM ELECTRODES, 2" X 4" FOAM, 4/PK

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