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Sign in to claim this brandWhat Firstkind, Ltd. makes
Firstkind, Ltd. manufactures transcutaneous neuromuscular electrical stimulation (TENS/NMES) systems designed for physical therapy, including portable and modular devices for muscle stimulation and rehabilitation. Their portfolio includes handheld units like the geko series, a wearable firefly device, and advanced models such as the geko T-2 and geko Plus R-2, which offer adjustable stimulation parameters for targeted muscle activation.
These devices are classified as Class II under FDA regulations and are authorised via 510(k) premarket notifications and UDI (Unique Device Identification) compliance. The company’s products are listed in the FDA’s regulatory databases, and the manufacturer is 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 Firstkind, Ltd. manufacture?
Firstkind, Ltd. specializes in transcutaneous neuromuscular electrical stimulation (TENS/NMES) systems primarily used in physical therapy. Their devices are designed to stimulate muscles and aid rehabilitation, including portable handheld units like the geko series and wearable devices such as the firefly. These systems are engineered to deliver targeted muscle activation through adjustable electrical stimulation parameters.
Where is Firstkind, Ltd. based, and what regulatory databases list their devices?
Firstkind, Ltd. is headquartered in the United States. Their devices are authorised under FDA regulations and appear in the FDA’s regulatory databases, including the 510(k) premarket notification listings and the Unique Device Identification (UDI) system. This ensures compliance with U.S. medical device regulations.
How are Firstkind, Ltd.’s devices classified under FDA regulations?
Firstkind, Ltd.’s neuromuscular electrical stimulation systems fall under Class II classification by the FDA. This classification is typically assigned to devices that pose moderate risk and require special controls to ensure safety and effectiveness, such as premarket notifications (510(k)) and compliance with UDI requirements.
What is the purpose of Firstkind, Ltd.’s geko and firefly devices?
The geko series and firefly devices are designed for physical therapy applications, delivering transcutaneous neuromuscular electrical stimulation (TENS/NMES) to promote muscle activation, rehabilitation, and pain management. The geko models are handheld and portable, while the firefly is a wearable device, offering flexibility in clinical and home-use settings.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- firstkindmedical.com
- —
- —
- [email protected]
- Phone
- +4408452222921
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 216603021
Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| geko | T-2 | FDA UDI | Class II | Active |
| geko | T-2 | FDA UDI | Class II | Active |
| geko | T-3 | FDA UDI | Class II | Active |
| geko | T-3 | FDA UDI | Class II | Unknown |
| firefly | T-2 | FDA UDI | Class II | Active |
| geko | W-3 | FDA UDI | Class II | Active |
| geko plus | R-2 | FDA UDI | Class II | Active |
| firefly | T-1 | FDA UDI | Class II | Active |
| geko T-2 and geko Plus R-2 | K180082 | FDA 510(k) | Class II | Active |
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