FDA.reportPublic FDA data

RecoverPad

Primary DI
10851610008156
Brand
RecoverPad
Company
SAUVRE INTERNATIONAL, LTD.
Model
REPS2040
Catalog number
REPS2040
Device description
Transcutaneous electrical stimulation electrode, Square, 50x100mm
Published
2017-12-19
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
true
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851610008135PackageGS144In Commercial Distribution
00851610008142PackageGS120In Commercial Distribution
00851610008159PackageGS18In Commercial Distribution
10851610008132PackageGS136In Commercial Distribution
10851610008149PackageGS176In Commercial Distribution
10851610008156PackageGS170In Commercial Distribution
00851610008050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851610008135008516100081358516100081350851610008135
00851610008142008516100081428516100081420851610008142
00851610008159008516100081598516100081590851610008159
1085161000813210851610008132
1085161000814910851610008149
1085161000815610851610008156
00851610008050008516100080508516100080500851610008050

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrodeA non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length100Millimeter
Width50Millimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Temperature0 Degrees Celsius45 Degrees Celsius

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080557421
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
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
00851610008012Medical Science Products5050-WCSD5050-WCSD2017-10-19
00851610008036RecoverPadREPS1515REPS15152017-12-19
00851610008043RecoverPadREPS2020REPS20202017-12-19
00851610008050RecoverPadREPS2040REPS20402017-12-19
00851610008067RecoverPadREPS4560REPS45602017-12-19
00851610008180EASLIEFESLF5050ESLF50502018-01-12
00851610008197EASLIEFESLF4040ESLF40402018-01-12
00851610008203EASLIEFESLF50100ESLF501002018-01-12
00851610008210EASLIEFESLF93150ESLF931502018-01-12
00851610008289RecoverPadREPSHSREPSHS2018-01-08
00864666000305Medical Science Products4040-SD4040-SD2017-06-08
00864666000336Medical Science Products5050-FSD5050-FSD2017-08-08
00864666000343Medical Science Products5090-FSD5090-FSD2017-10-19
00864666000367Medical Science Products110150-FSD110150-FSD2018-01-10
00851610008319Medical Science ProductsTS-1211TS-12112018-05-29
10851610008347Medical Science ProductsTS-1211TS-12112018-05-29
00851610008326Medical Science ProductsCOM-TENSCOM-TENS2018-05-29
10851610008026Medical Science Products5050-WCSD5050-WCSD2017-10-19
10851610008095RecoverPadREPS1515REPS15152017-12-19
10851610008125RecoverPadREPS2020REPS20202017-12-19

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06973602730894MEDLOTTOP-RANK HEALTH CARE CO., LTD.GXY2026-06-08
08720791379032Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379049Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379063Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
08720791379087Technomed EuropeTechnomed Engineering B.V.GXY2026-06-03
00816312028072Rhythmlink®RHYTHMLINK INTERNATIONAL, LLCGXY2026-06-01
00850055335004iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335011iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
00850055335028iTENSPAIN MANAGEMENT TECHNOLOGIES, INC.GXY2026-05-04
08057971594733Remote Wave ElectrodeBIONIT LABS SRLGXY2026-03-18
08720791375911CadwellTechnomed Engineering B.V.GXY2025-03-12
08057971592685Wave ElectrodeBIONIT LABS SRLGXY2025-01-21
08720791377564NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791377595NeuroradiumTechnomed Engineering B.V.GXY2024-11-22
08720791375591CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375614CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375638CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375652CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791375676CadwellTechnomed Engineering B.V.GXY2024-10-04
08720791374426NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374440NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374457NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374471NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374495NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374518NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374532NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374556NeuroguardTechnomed Engineering B.V.GXY2024-05-22
08720791374693MagstimTechnomed Engineering B.V.GXY2024-05-22
08720791372125CadwellTechnomed Engineering B.V.GXY2024-05-02
08720791372149CadwellTechnomed Engineering B.V.GXY2024-05-02