Empi
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Empi is a medical device manufacturer, with 74 devices listed in FDA 510(k) and FDA GUDID (FDA Class II and I) as of 13 Nov 2026.
- Devices
- 74
Registry facts
- Registries
- FDA 510(k) 59
- FDA GUDID 15
- Device classes
- FDA Class II 72
- FDA Class I 2
What Empi makes
Empi manufactures reusable iontophoresis systems and single-use drug-delivery patches for transdermal medication administration, including disposable electrodes in varying sizes (1.5 mL to 4.0 mL) and reusable controllers for iontophoresis treatment. Their product line also includes battery chargers for noninvasive devices and complete iontophoresis kits with safety features.
Empi’s devices are classified under FDA categories Class I and Class II, with records available in the FDA’s 510(k) and Unique Device Identifier (UDI) registries.
Catalogue
Search and filter all 74 devicesShowing 1-50 of 74
Frequently asked questions
How many devices does Empi have in the registry?
The registry currently lists 74 devices for Empi. Devices recorded under merged duplicate company entries are counted once.
Which registries list Empi's devices?
Among its 50 most recently registered devices, Empi has devices listed in FDA 510(k) (35 devices) and FDA GUDID (15 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Empi's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Empi's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Empi in the registry?
The most recently registered devices listed for Empi include Dupel Kit Iontophoresis Device 199518-001, Iontophoresis Dupel Blue Butterfly 2.0 mL 199334-001, Kit, Hybresis Controller 199587-001 and Iontophoresis Electrode Large 4.0 mL 4"x4" Box of 12 198810-001.