Sadler Electronics
ZA Last updated 22 Oct 2026
Is this your brand? Sign in to claim this brand
- Devices
- 1
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Accu-Pulse Tens Unit Ref K010203
What Sadler Electronics makes
Sadler Electronics manufactures the ACCU-PULSE TENS Unit, a transcutaneous electrical nerve stimulation (TENS) device designed for pain management.
The ACCU-PULSE TENS Unit is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Frequently asked questions
What types of medical devices does Sadler Electronics manufacture?
Sadler Electronics specializes in transcutaneous electrical nerve stimulation (TENS) devices. Their primary product, the ACCU-PULSE TENS Unit, is designed specifically for pain management by delivering controlled electrical impulses through the skin to alleviate discomfort.
Where is Sadler Electronics based?
Sadler Electronics is headquartered in the United States. The company’s location is relevant for understanding regulatory oversight and compliance, as it operates within the US medical device framework.
How are Sadler Electronics’ devices classified in the US?
The ACCU-PULSE TENS Unit from Sadler Electronics is classified as a Class II medical device in the US. This classification is determined by the FDA based on the device’s intended use and risk level—Class II devices require special controls beyond general controls to ensure safety and effectiveness, such as performance standards or post-market surveillance.
Which regulatory registries or databases list Sadler Electronics’ devices?
Sadler Electronics’ ACCU-PULSE TENS Unit is listed under the FDA’s 510(k) pathway, meaning it has undergone the required premarket notification process to demonstrate substantial equivalence to a legally marketed predicate device. This registration confirms compliance with US regulatory requirements for Class II devices.
Information
- Country
- ZA