Electro Therapeutic Devices, Inc.
Country not established FDA
- Devices
- 9
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Electro Therapeutic Devices, Inc. makes
Electro Therapeutic Devices, Inc. manufactures transcutaneous electrical nerve stimulation (TENS) units, including the ETI TENS BELT and MYOSTIM 804, designed for pain relief and muscle stimulation. The company also produces disposable acupuncture needles under the ADDIQUIP brand and electrical muscle stimulators like the MYOAID and MYOSTIM EX. Additional offerings include the THERATHERM device, likely for thermal therapy, and the TENSAID system for nerve stimulation.
The company’s products are classified as Class II medical devices under FDA regulations, with most authorised via the 510(k) pathway. These devices are listed in the FDA’s 510(k) registry. The manufacturer operates from the United States.
Catalogue
- GUDID
Eti Tens Belt Ref K843119
510(k) 510(k)Addiquip Disposable Acupuncture Needles Ref K981272
510(k) 510(k)Electrical Muscle Stimulator Model Myoaid Ref K875317
510(k) 510(k)Transcutaneous Electr. Nerve Stimul Myostim 804 Ref K853718
510(k) 510(k)'tensaid' Ref K863567
510(k) 510(k)Transcutaneous Elect. Nerve Stimul-Myostim 410 Ref K853719
510(k) 510(k)'myostim Ex' Ref K863568
510(k) 510(k)Theratherm Ref K770686
510(k) 510(k)
FDA establishments
- Electro Therapeutic Devices Inc Markham Ontario · CA FEI 3006517314
Frequently asked questions
How many devices does Electro Therapeutic Devices, Inc. have in the registry?
The registry currently lists 9 devices for Electro Therapeutic Devices, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Electro Therapeutic Devices, Inc.'s devices?
Among its 9 most recently registered devices, Electro Therapeutic Devices, Inc. has devices listed in FDA 510(k) (8 devices) and FDA GUDID (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Electro Therapeutic Devices, Inc.'s devices fall under?
Among its 9 most recently registered devices, the classes recorded for Electro Therapeutic Devices, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Electro Therapeutic Devices, Inc. in the registry?
The most recently registered devices listed for Electro Therapeutic Devices, Inc. include Accu-O-Matic Sp series, ETI TENS BELT, ADDIQUIP DISPOSABLE ACUPUNCTURE NEEDLES and ELECTRICAL MUSCLE STIMULATOR MODEL MYOAID.
Which FDA establishments are linked to Electro Therapeutic Devices, Inc.?
1 FDA establishment is linked to Electro Therapeutic Devices, Inc. in the registry; they are listed on the company page.