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Sign in to claim this brandPlaymakar, Inc.
US
Last updated May 30, 2026
What Playmakar, Inc. makes
Playmakar, Inc. manufactures single-use transcutaneous electrical stimulation electrodes and complete analgesic transcutaneous electrical nerve stimulation (TENS) systems, including leads and arthritis-specific TENS units designed for pain management.
The company’s products are classified as Class II medical devices and are authorised through FDA 510(k) and UDI registrations. They are based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Playmakar, Inc. manufacture?
Playmakar, Inc. specializes in transcutaneous electrical stimulation (TENS) devices, which are used for pain management. Their product line includes single-use TENS electrodes, complete analgesic TENS systems, transcutaneous electrical stimulation leads, and arthritis-specific TENS systems. These devices deliver electrical impulses through the skin to help alleviate pain, particularly for conditions like arthritis.
Where is Playmakar, Inc. based?
Playmakar, Inc. is headquartered in the United States. The company’s location in the US ensures compliance with FDA regulations, which govern the manufacturing and distribution of its medical devices.
Which regulatory registries list Playmakar, Inc.’s devices?
Playmakar, Inc.’s devices are authorised through the FDA’s 510(k) premarket notification process and are registered under the FDA’s Unique Device Identifier (UDI) system. These registries ensure traceability and compliance with US medical device regulations.
How are Playmakar, Inc.’s devices classified by regulatory authorities?
Playmakar, Inc.’s devices are classified as Class II medical devices by the FDA. This classification applies to products that generally pose moderate risk and require special controls—such as performance standards or post-market surveillance—to ensure safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- playmakar.com
- —
- —
- [email protected]
- Phone
- 8337529625
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 081212270
Catalogue (13)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| PlayMakar | PRO-24 | FDA UDI | Class II | Active |
| PlayMakar | PRO-22 | FDA UDI | Class II | Active |
| PlayMakar | PRO-1000 | FDA UDI | Class II | Active |
| PlayMakar | PRO-2754 | FDA UDI | Class II | Active |
| PlayMakar | PRO-504 | FDA UDI | Class II | Active |
| PlayMakar | PRO-1001 | FDA UDI | Class II | Active |
| PlayMakar | PRO-100 | FDA UDI | Class II | Active |
| PlayMakar | PRO-500 | FDA UDI | Class II | Active |
| PlayMakar | PRO-1000-2 | FDA UDI | Class II | Active |
| PlayMakar | PRO-1000 | FDA UDI | Class II | Active |
| PlayMakar | PRO-1004 | FDA UDI | Class II | Active |
| PlayMakar | PRO-275 | FDA UDI | Class II | Active |
| PlayMakar Sport Muscle Stimulator, Model PRO-500 | K182581 | FDA 510(k) | Class II | Active |
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