FDA.reportPublic FDA data

BLUE HAND

Primary DI
00817120021460
Brand
BLUE HAND
Company
BIO PROTECH USA, INC.
Model
1515SQ XTFO
Device description
1.5"x1.5" sq., foam, 1 pouch(2 pairs per pouch)
Published
2026-07-07
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K042301000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042301000PROTENS ELECTRODEBio Protech, Inc.2004-09-03GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10817120021467PackageGS110In Commercial Distribution
20817120021464PackageGS110In Commercial Distribution
30817120021461PackageGS15In Commercial Distribution
00817120021460PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1081712002146710817120021467
2081712002146420817120021464
3081712002146130817120021461
00817120021460008171200214608171200214600817120021460

GMDN Terms#

Term, Definition table
TermDefinition
Transcutaneous electrical stimulation electrode, single-useAn 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 (EMS), 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-use device.

Regulatory Flags#

DUNS number
789127011
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
00817120020609BLUE HAND03RD XTFA2026-07-07
00817120021477BLUE HAND1.5RD XTFO2026-07-07
00817120021484BLUE HAND02RD XTFO2026-07-07
00817120021491BLUE HAND22SQ XTFO2026-07-07
00817120021507BLUE HAND24RT XTFO2026-07-07
00817120021514BLUE HAND03RD XTFO2026-07-07
00817120020067BLUE HAND1515SQ XTFA2026-07-07
00817120020050Bio Protech48482026-05-07
00817120020043Bio Protech48482016-06-15
00817120020340Bio Protech4848WCBZGN(NST)2016-06-21
00817120021088Bio ProtechSG15R (Lifelines)2017-08-09
00817120021095Bio ProtechSG15G (Lifelines)2017-08-09
00817120021101Bio ProtechNCS-1334 (Lifelines)2017-08-09
00817120021118Bio ProtechNCS-SG15 (Lifelines)2017-08-09
00817120021125Bio ProtechMF2409 (Lifelines)2017-08-09
00817120020005Bio Protech MaxTens 1k 2016-06-15
00817120020074Bio ProtechMaxEMS 1k2016-06-16
00817120020081Bio Protech MaxEMS 2k2016-06-17
00817120020562Bio Protech MaxTens 1k Unit2016-09-01
00817120020036Bio Protech MaxTens 2k 2016-06-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08682250582004Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08682250582011Elde MedicalELDE MEDIKAL SANAYI VE TICARET ANONIM SIRKETIGXY2026-07-08
08720791378172Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378189Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378196Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378202Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378219Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378226Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378233Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378240Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378257Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378264Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378271Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378288Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378295Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378301Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378318Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378325Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378332Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378349Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378356Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378363Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378370Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378387Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378394Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378400Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378417Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378424Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378431Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08
08720791378448Technomed EuropeTechnomed Engineering B.V.GXY2026-07-08