# K201958: ETD Family of Electrotherapy Devices

- Pathway: 510(k) (Traditional)
- Applicant: Therasigma, LLC
- Decided: Aug 4, 2020 after 21 days
- Product code: IPF (Stimulator, Muscle, Powered)
- Device class: 2
- Regulation: 21 CFR 890.5850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
ETD100 TENS Device TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. ETD200 NMES Device NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. ETD300 TENS and NMES Combination Device TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. ETD400 IFCS Device (IFCS = Interferential Current Stimulation) IFCS Mode: Interferential Current Stimulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. ETD500 TENS and IFCS Combination Device TENS Mode:Transcutaneous Electrical Nerve Stimulation for Pain Relief: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. ETD600 NMES and IFCS Combination Device NMES Mode: Neuromuscular Electrical Stimulation: Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation: Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. ETD700 TENS and NMES and IFCS Combination Device TENS Mode: Transcutaneous Electrical Nerve Stimulation for Pain Relief. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain. NMES Mode: Neuromuscular Electrical Stimulation. Relaxation of muscle spasm, increasing local blood circulation, maintaining and increasing range of motion, preventing or retarding muscle disuse atrophy, muscle reeducation, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis. IFCS Mode: Interferential Current Simulation. Symptomatic relief and management of chronic pain and/or as an adjunctive treatment for the management of post-surgical and post-traumatic pain.

Source page: https://510kreport.com/device/K201958
Methodology: https://510kreport.com/methodology