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PlayMakar

FDA UDI

Class II (US FDA UDI)

by Playmakar, Inc.

Identity

Trade Name
PlayMakar FDA UDI
Generic Name
Arthritis TENS system FDA UDI
Device Name
PLAYMAKAR SPORT MUSCLE STIMULATOR FDA UDI
Model / Reference
PRO-500 FDA UDI
Description
PLAYMAKAR SPORT MUSCLE STIMULATOR FDA UDI

Identifiers

Catalog Number
PRO-500 FDA UDI
Primary DI / UDI-DI
00856675008045 FDA UDI
510(k) Number
K182581 FDA UDI
FDA Product Code
NGX FDA UDI
NYN FDA UDI
NUH FDA UDI
GMDN Term
Arthritis TENS system FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
890.5850 FDA UDI
882.5890 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI

Category: Analgesic transcutaneous electrical nerve stimulation systemTranscutaneous electrical stimulation leadArthritis TENS system

PlayMakar by Playmakar, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Arthritis TENS system.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Playmakar, Inc.

Sources (1)

  • FDA UDI bfd00cee-ed14-4b6d-ad6f-cdbdcad671b9 36 fields · synced May 30, 2026