Promedtek, Inc.
United StatesFDA applicant, unverified FDA FEI 3007134923
Promedtek, Inc. is a medical device manufacturer, with 4 devices listed in FDA 510(k) and FDA GUDID (FDA Class II) as of 14 Nov 2026.
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 0
Registry facts
- Registries
- FDA 510(k) 2
- FDA GUDID 2
- Device classes
- FDA Class II 4
- Identifiers
- FDA FEI 3007134923
- DUNS 604679527
At a glance
Market reach
- United States
- FDA FEI
What Promedtek, Inc. makes
Promedtek, Inc. manufactures short-wave diathermy treatment systems designed for professional medical use, including the Replexa+ Device and its applicator, as well as standalone models like the MODEL PMT850 and ProMedTek Model C1400. These devices deliver controlled thermal energy for therapeutic applications in clinical settings.
The company’s products are classified as Class II devices under FDA regulations and are listed in the FDA’s 510(k) and UDI databases.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: 510(k) Registry: GUDID
Model PMT850 Ref K070931
Regimes: 510(k) Registry: 510(k)ProMedTek Model C1400 Shortwave Diathermy Device Ref K162240
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3007134923
- DUNS number
- 604679527
- Address
- 15475 N Greenway Hayden Loop Ste 21-22b, Scottsdale, AZ, 85260
- info@promedtek.com
- Phone
- 8663882410
Frequently asked questions
How many devices does Promedtek, Inc. have in the registry?
The registry currently lists 4 devices for Promedtek, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Promedtek, Inc.'s devices?
Among its 4 most recently registered devices, Promedtek, Inc. has devices listed in FDA 510(k) (2 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Promedtek, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Promedtek, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Promedtek, Inc. in the registry?
The most recently registered devices listed for Promedtek, Inc. include Replexa+ Device C1416, Replexa+ Treatment Applicator C1416, MODEL PMT850 and ProMedTek Model C1400 Shortwave Diathermy Device.