FDA.reportPublic FDA data

PlayMakar

Primary DI
00856675008045
Brand
PlayMakar
Company
PLAYMAKAR INC.
Model
PRO-500
Catalog number
PRO-500
Device description
PLAYMAKAR SPORT MUSCLE STIMULATOR
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
NGXStimulator, Muscle, Powered, For Muscle Conditioning
NUHStimulator, Nerve, Transcutaneous, Over-The-Counter
NYNStimulator, Electrical, Transcutaneous, For Arthritis

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NGXStimulator, Muscle, Powered, For Muscle ConditioningPhysical Medicine2
NUHStimulator, Nerve, Transcutaneous, Over-The-CounterNeurology2
NYNStimulator, Electrical, Transcutaneous, For ArthritisNeurology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182581000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182581000PlayMakar Sport Muscle Stimulator, Model PRO-500Playmakar, Inc.2018-11-21NUH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00856675008151PackageGS110In Commercial Distribution
00856675008168PackageGS14In Commercial Distribution
00856675008045PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00856675008151008566750081518566750081510856675008151
00856675008168008566750081688566750081680856675008168
00856675008045008566750080458566750080450856675008045

GMDN Terms#

Term, Definition table
TermDefinition
Arthritis TENS systemAn assembly of battery-powered devices intended to be used as adjunctive therapy in reducing the level of pain and stiffness associated with rheumatoid arthritis or osteoarthritis by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of an external electric current generator and electrodes that are placed on the skin near a joint(s) to provide the electrical stimulus to the painful area. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for routine home-use to treat symptoms of rheumatoid arthritis (RA) of the hands and osteoarthritis of the knee.

Contacts#

Phone, Email table
PhoneEmail
8337529625IAM@PlayMakar.com

Regulatory Flags#

DUNS number
081212270
Device count
1
Lot or batch
true
Serial number
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
00856675008267PlayMakarPRO-24PRO-242019-02-22
00856675008274PlayMakarPRO-504PRO-5042019-02-22
00856675008007PlayMakarPRO-1000PRO-10002018-07-20
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
00860009281806NoodlePourang Bral Dds LLCNUH2026-06-09
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680085AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680092AUVONShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNGX2026-06-03
06978452680108NURSALShenzhen Jiantuo Electronics Co., LtdNUH2026-06-03
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-06-02
06971712722075MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-06-02
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-30
06971712726943MASTOGOHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-30
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNUH2026-05-28
06971712722990SalityHong Qiangxing (Shen Zhen) Electronics LimitedNGX2026-05-28
03770018808086actiTENSSUBLIMEDNUH2026-05-27
03770018808086actiTENSSUBLIMEDNYN2026-05-27
03770018808086actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNUH2026-05-27
03770018808093actiTENSSUBLIMEDNGX2026-05-27
03770018808093actiTENSSUBLIMEDNYN2026-05-27
03770018808109actiTENSSUBLIMEDNUH2026-05-27
03770018808109actiTENSSUBLIMEDNGX2026-05-27
03770018808109actiTENSSUBLIMEDNYN2026-05-27
03770018808116actiTENSSUBLIMEDNUH2026-05-27
03770018808116actiTENSSUBLIMEDNGX2026-05-27
03770018808116actiTENSSUBLIMEDNYN2026-05-27
03770018808253actiTENS MiniSUBLIMEDNUH2026-05-27
03770018808253actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808253actiTENS MiniSUBLIMEDNYN2026-05-27
03770018808260actiTENS MiniSUBLIMEDNGX2026-05-27
03770018808260actiTENS MiniSUBLIMEDNUH2026-05-27