FDA.reportPublic FDA data

Reserv

Primary DI
00815991022104
Brand
Reserv
Company
BOXOUT, LLC
Model
RSV2IRU10
Catalog number
RSV2IRU10
Device description
RESERV TENS ELECTRODE, 2" round, . 4 pads/pack, 10 packs/bag, 50 bags/case
Published
2018-12-31
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

Contact Domains#

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
10815991022101PackageGS110In Commercial Distribution
20815991022108PackageGS1500In Commercial Distribution
00815991022104PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081599102210110815991022101
2081599102210820815991022108
00815991022104008159910221048159910221040815991022104

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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-528-2152info@bodysportproducts.com

Regulatory Flags#

DUNS number
066689993
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
true
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00815991025167BodyMedBDMNEBCOMREU2025-07-17
00815991024030BodyMedBDMNTRGVLRGBDMNTRGVLRG2024-12-04
20815991024041BodyMedBDMNTRGVMEDBDMNTRGVMED2024-12-04
20815991024058BodyMedBDMNTRGVSMBDMNTRGVSM2024-12-04
20815991024065BodyMedBDMNTRGVXLGBDMNTRGVXLG2024-12-04
20815991024072BodyMedBDMNTRGVXSBDMNTRGVXS2024-12-04
20815991025185BodyMedBDMPULSEOXBDMPULSEOX2024-10-11
20815991025062BodyMedBDMRNK2023-08-14
00815991025006BodyMedBDMEFS602023-05-23
00815991025013BodyMedBDMCTS602023-05-23
00815991024771BodyMedBDMARW502023-02-17
20815991024782BodyMed BDMSBW252023-02-17
00815991024689BodyMedBDMSBS102022-12-05
20815991024690BodyMedBDMSBS10R2022-12-05
20815991024706BodyMedBDMSBS142022-12-05
00815991024726BodyMedBDMCSBS102022-12-05
20815991024737BodyMedBDMCSBS10R2022-12-05
20815991024744BodyMedBDMCSBS142022-12-05
20815991024843BodyMedBDMCSBS10SAM2022-12-05
20815991024850BodyMedBDMCSBS10RSAM2022-12-05

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