FDA.reportPublic FDA data

N/A

Primary DI
80092237617362
Brand
N/A
Company
Roscoe Medical
Model
WQ8000
Device description
78 Clinical Lead Wires
Published
2016-10-13
Public version status
Update
Distribution status
Not 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
IKDCable, Electrode

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IKDCable, ElectrodePhysical Medicine2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
80092237617362PackageGS1500Not in Commercial Distribution
00092237617366PrimaryGS10
01092237617365Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
8009223761736280092237617362
00092237617366000922376173660922376173660092237617366
01092237617365010922376173651092237617365

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation leadA non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
440-572-1962CustomerService@compasshealthbrands.com
800-376-7263customerservice@compasshealthbrands.com

Regulatory Flags#

DUNS number
022542271
Device count
2
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
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
80092237604225Wheelchair Foam Cushion - 22 x 18 x 3WCBF-22832020-11-11
80092237604232Wheelchair Foam Cushion - 24 x 18 x 3WCBF-24832020-11-11
80092237604300Wheelchair Back Cushion Foam - 16 x 17BKF-16172020-11-11
80092237604317Wheelchair Back Cushion Foam - 18 x 17BKF-18172020-11-11
80092237604324Wheelchair Back Cushion Foam - 20 x 19BKF-20192020-11-11
80092237604331Wheelchair Back Cushion Foam - 22 x 19BKFB-22192020-11-11
80092237604270Coccyx Cushion Memory Foam - 18 x 16 x 3COC-182020-11-11
80092237605468N/ADQ78442016-10-12
80092237611629N/ADQ84502016-10-12
80092237616655N/ADE75022016-10-12
80092237616686N/ADI47382016-10-12
80092237616709N/ADI81952016-10-12
80092237616754N/ADS22022016-10-12
80092237616761N/ADS50022016-10-12
80092237617515N/ADI37172016-10-12
80813520010772N/ADT30022016-10-12
80813520011939N/ADI10102016-10-12
80092237616440N/ADQ8000W52016-10-12
60092237603118Roscoe Medical500402016-10-05
80092237603181Roscoe Medical500182016-10-07

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
06946725572108APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572115APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725572122APKAPK Technology Co.,Ltd.IKD2026-10-13
06946725571712APKAPK Technology Co.,Ltd.IKD2026-07-01
06946725500866APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500873APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500880APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500897APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500903APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500910APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500927APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500934APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500941APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500958APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500965APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500972APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500989APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725500996APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501009APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501016APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501030APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501047APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501054APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501061APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501078APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501085APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501092APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501108APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501115APKAPK Technology Co.,Ltd.IKD2025-07-22
06946725501122APKAPK Technology Co.,Ltd.IKD2025-07-22