FDA.reportPublic FDA data

Essential Digital TENS System

Primary DI
00754756750008
Brand
Essential Digital TENS System
Company
ESSENTIAL MEDICAL SUPPLY INC
Model
S2000
Published
2017-04-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10754756750005PackageGS130In Commercial Distribution
00754756750008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1075475675000510754756750005
00754756750008007547567500087547567500080754756750008

GMDN Terms#

Term, Definition table
TermDefinition
Analgesic transcutaneous electrical nerve stimulation systemAn assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.

Contacts#

Phone, Email table
PhoneEmail
407-770-0710michael.hoepner@essentialmedicalsupply.com

Regulatory Flags#

DUNS number
189331325
Device count
1
Kit
true
Lot or batch
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00754756740009Essential TENS SystemS1000 2017-04-11
00754756740016TENS Electrode SetS1000E2017-04-11
10754756740006Essential TENS SystemS1000 2017-04-11
20754756740010TENS Electrode SetS1000E2017-04-11
10754756750005Essential Digital TENS SystemS20002017-04-11
00754756388003Endurance Standard Alternating Pressure Bubble PadD88002017-11-07
00754756390013Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07
00754756380007Endurance Standard Alternating Pressure PumpD80002017-11-07
00754756380014Endurance Standard Alternating Pressure Pump & Pad ComboD8000C 2017-11-07
10754756388000Endurance Standard Alternating Pressure Bubble PadD88002017-11-07
00754756388010Endurance Standard Alternating Pressure Bubble Pad w/FlapsD8800EX2017-11-07
00754756390006Endurance Deluxe Alternating Pressure PumpD90002017-11-07
10754756390010Endurance Deluxe Alternating Pressure Pump & Pad ComboD9000C2017-11-07