FDA.reportPublic FDA data

PlayMakar

Primary DI
10856675008011
Brand
PlayMakar
Company
PLAYMAKAR INC.
Model
PRO-100
Catalog number
PRO-100
Device description
PLAYMAKAR MINI WIRELESS TENS UNIT
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
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121353000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121353000MINI PATCHWell-Life Healthcare Limited2012-09-07NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10856675008011PackageGS1160In Commercial Distribution
00856675008014PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085667500801110856675008011
00856675008014008566750080148566750080140856675008014

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
8337529625IAM@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
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

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