FDA.reportPublic FDA data

PlayMakar

Primary DI
00856675008267
Brand
PlayMakar
Company
PLAYMAKAR INC.
Model
PRO-24
Catalog number
PRO-24
Device description
"PLAYMAKAR SPORT SNAP ELECTRODES, 2"" x 4"", 2/Pack"
Published
2019-02-22
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
OTC
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
GXYElectrode, Cutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
GXYElectrode, CutaneousNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K082065000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K082065000WELL LIFE SELF ADHESIVE ELECTRODE / MODELS: CM, FA, PU AND SPWell-Life Healthcare Limited2009-04-10GXY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856675008264PackageGS1100In Commercial Distribution
00856675008267PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085667500826410856675008264
00856675008267008566750082678566750082670856675008267

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.

Contacts#

Phone, Email table
PhoneEmail
8337529625IAM@PlayMakar.com

Regulatory Flags#

DUNS number
081212270
Device count
1
Lot or batch
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00856675008724PlayMakarPRO-1000-2PRO-1000-22021-09-16
00856675008755PlayMakarPRO-1000PRO-10002021-09-16
00856675008014PlayMakarPRO-100PRO-1002019-02-22
00856675008021PlayMakarPRO-275PRO-2752019-02-22
00856675008038PlayMakarPRO-2754PRO-27542019-02-22
00856675008052PlayMakarPRO-1001PRO-10012019-02-22
00856675008106PlayMakar PRO-1004PRO-10042019-02-22
00856675008250PlayMakarPRO-222019-02-22
00856675008274PlayMakarPRO-504PRO-5042019-02-22
00856675008007PlayMakarPRO-1000PRO-10002018-07-20
00856675008045PlayMakarPRO-500PRO-5002019-02-22
00856675008168PlayMakarPRO-500PRO-5002019-02-22
20856675008056PlayMakarPRO-1001PRO-10012019-02-22
10856675008011PlayMakarPRO-100PRO-1002019-02-22
00856675008205PlayMakarPRO-275PRO-2752019-02-22
00856675008212PlayMakarPRO-2754PRO-27542019-02-22
00856675008236PlayMakar PRO-1004PRO-10042019-02-22
10856675008257PlayMakarPRO-222019-02-22
10856675008264PlayMakarPRO-24PRO-242019-02-22
20856675008278PlayMakarPRO-504PRO-5042019-02-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850080988640AUVONUAN HEALTHCARE LIMITEDGXY2026-07-22
00850080988633AUVONUAN HEALTHCARE LIMITEDGXY2026-07-17
00850080988602AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988619AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850080988626AUVONUAN HEALTHCARE LIMITEDGXY2026-07-16
00850053287411ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287428ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287442ReCureNiche Biomedical, Inc.GXY2026-07-14
00850053287459ReCureNiche Biomedical, Inc.GXY2026-07-14
00850080988589AUVONUAN HEALTHCARE LIMITEDGXY2026-07-14
06971292004318AUVONShenzhen Yuwen E-Commerce Co., Ltd.GXY2026-07-13
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