FDA.reportPublic FDA data

PlayMakar

Primary DI
00856675008212
Brand
PlayMakar
Company
PLAYMAKAR INC.
Model
PRO-2754
Catalog number
PRO-2754
Device description
PLAYMAKAR PRO SELF ADHESIVE ELECTRODES, 2.75" X 4", 2/PACK
Published
2019-02-22
Public version status
New
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

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
00856675008212PackageGS1100In Commercial Distribution
00856675008038PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856675008212008566750082128566750082120856675008212
00856675008038008566750080388566750080380856675008038

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
8338529625IAM@PlayMakar.com

Regulatory Flags#

DUNS number
081212270
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
false
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
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
00856675008267PlayMakarPRO-24PRO-242019-02-22
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
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