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Sign in to claim this brandDalton Medical Corp.
US
Last updated May 23, 2026
What Dalton Medical Corp. makes
Dalton Medical Corp. manufactures mobility aids and assistive devices, including non-bariatric push-rim manual wheelchairs, power-assisted and electric-motor-driven scooters, collapsible walkers, and basic electric home beds. Their portfolio also covers air-filled mattress overlays, shower benches, manual commodes, and patient lifts for home and clinical use.
The company’s devices are regulated under FDA Class I and Class II classifications, with many authorised via 510(k) premarket notifications and the FDA’s Unique Device Identifier (UDI) system. Products are listed in the FDA’s regulatory databases, reflecting compliance with US medical device requirements.
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 Dalton Medical Corp. manufacture?
Dalton Medical Corp. specializes in mobility aids and assistive devices designed for home and clinical use. Their product lineup includes non-bariatric push-rim manual wheelchairs, power-assisted and electric-motor-driven scooters, foldable walkers, basic electric home beds, air-filled mattress overlays, shower benches, manual commodes, and patient lifts. These devices are intended to support independence and accessibility for users with mobility limitations.
Where is Dalton Medical Corp. based, and does that affect its regulatory compliance?
Dalton Medical Corp. is based in the United States. Since the company operates within the US market, its devices are subject to FDA regulations, including premarket notifications (510(k)) and the Unique Device Identifier (UDI) system. The FDA’s regulatory framework applies uniformly across the country, ensuring compliance standards are met regardless of regional location.
Which regulatory registries or databases list Dalton Medical Corp.’s devices?
Dalton Medical Corp.’s devices are listed in the FDA’s regulatory databases, specifically through the 510(k) premarket notification process and the FDA’s Unique Device Identifier (UDI) system. These registries confirm that the devices meet US medical device requirements and are authorised for commercial distribution. The inclusion in these systems reflects compliance with FDA guidelines for Class I and Class II devices.
How are Dalton Medical Corp.’s devices classified under FDA regulations?
Dalton Medical Corp.’s devices fall under FDA Class I and Class II classifications. Class I devices generally pose minimal risk and may require general controls, while Class II devices involve a higher level of risk and may require special controls to ensure safety and effectiveness. The classification determines the regulatory pathway, such as 510(k) premarket notifications for Class II, ensuring each device meets applicable standards before authorisation.
Why do some of Dalton Medical Corp.’s devices require a 510(k) premarket notification?
The FDA requires a 510(k) premarket notification for Class II devices, which include many of Dalton Medical Corp.’s products like power-assisted wheelchairs, electric scooters, and patient lifts. This process demonstrates that the device is substantially equivalent to a legally marketed predicate device in terms of safety and performance. It ensures that higher-risk assistive devices meet rigorous standards before entering the market, balancing innovation with user safety.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (164)
Page 4 of 4| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dalton Manual Wheelchair | K3DK18F | FDA UDI | Class I | Active |
| Dalton Geriatric Recliner | CW-D584 | FDA UDI | Class I | Unknown |
| Dalton Tile-In-Space Manual Wheelchair | K618EXP | FDA UDI | Class I | Active |
| Dalton Manual Wheelchair | K516FA | FDA UDI | Class I | Active |
| Dalton Manual Wheelchair | K418F0215 | FDA UDI | Class I | Active |
| Dalton Rollator | AR-4600AR | FDA UDI | Class I | Active |
| Dalton Clinical Recliner | CW-D677 | FDA UDI | Class I | Unknown |
| E-Power | K010395 | FDA 510(k) | Class II | Active |
| Tacahe Pc1350 Power Wheelchair | K080373 | FDA 510(k) | Class II | Active |
| Tacahe | K052534 | FDA 510(k) | Class II | Active |
| Model Segaego 4d Scooter | K071282 | FDA 510(k) | Class II | Active |
| Model Segaego 3d Scooter | K071284 | FDA 510(k) | Class II | Active |
| Primechair | K052496 | FDA 510(k) | Class II | Active |
| Primechair | K021199 | FDA 510(k) | Class II | Active |
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