Table 2.
FDA-cleared/approved electromagnetic neuromodulation devices for acute pain indications.
| Modality | FDA decision date | FDA-authorized use (summary)a | Applicant | Device | Authorization type | Source | Notes |
|---|---|---|---|---|---|---|---|
| TENS | 10/13/16 | Temporary relief of sore/aching muscle pain (strain-related musculoskeletal pain) | Counter Scientific Development (GZ) Ltd | OTC TENS Device, Model PTS-IV | 510(k) | FDA 510(k) K161537 | |
| TENS | 6/3/16 | Adjunctive treatment for post-surgical and post-trauma acute pain | Djo, LLC | Strive | 510(k) | FDA 510(k) K153704 | Also indicated for chronic intractable pain and arthritis pain |
| TENS | 12/6/11 | Acute pain; post-surgical pain | Electronic Waveform Lab, Inc | H-Wave | 510(k) | FDA 510(k) K112485 | Also indicated for chronic pain |
| TENS | 3/27/24 | Post-surgical and post-traumatic acute pain | Wuxi Jiajian Medical Instrument Co., Ltd | TENS WMPS2-1 | 510(k) | FDA 510(k) K231425 | Also indicated for chronic intractable pain |
| TENS component of Combo Stimulator | 7/29/11 | Symptomatic relief of acute post-surgical and posttraumatic pain | Handelshaus Dittman GmbH | ETG 255 Combo Stimulator/TEN 260 Stimulator | 510(k) | FDA 510(k) K110390 | Also indicated for chronic intractable pain |
| Temporary percutaneous PNS | 1/25/23 | Post-operative and post-traumatic acute pain; up to 60 days | SPR Therapeutics, Inc | SPRINT | 510(k) | FDA 510(k) K223306 | Also indicated for chronic, intractable pain |
| Auricular percutaneous electrical nerve stimulation (PENS) | 1/31/22 | Post-operative pain following cesarean section delivery; up to 3 days | DyAnsys, Inc | Primary Relief | 510(k) | FDA 510(k) K213188 | |
| TMS (single-pulse, sTMS) | 12/13/13 | acute treatment of pain associated with migraine headache with aura. | eNeura Therapeutics | Neuralieve Cerena Transcranial Magnetic Stimulator | De Novo | FDA De Novo DEN130022 | Linked 510(k): K130556 |
| External trigeminal nerve stimulation | 9/15/17 | Acute treatment of migraine with or without aura | Cefaly Technology | Cefaly Acute | 510(k) | FDA 510(k) K171446 | |
| nVNS | 11/27/18 | Acute treatment of pain associated with migraine headache; also episodic cluster headache pain | electroCore, Inc | gammaCore Sapphire | 510(k) | FDA 510(k) K182369 | Also labeled for adjunctive preventive treatment of episodic cluster headache |
| Remote Electrical Neuromodulation (REN) | 1/22/21 | Acute treatment of migraine with or without aura | Theranica Bio-Electronics, Ltd | Nerivio | 510(k) | FDA 510(k) K203181 | Prescription, home-use REN; indicated for migraine (≥12 years) |
| External trigeminal + occipital nerve stimulation (cranial TENS) | 2/16/21 | Acute treatment of migraine with or without aura | Neurolief, Ltd | Relivion MG | 510(k) | FDA 510(k) K203419 |
Representative devices organized by modality and labeled acute-use indication, including acute post-operative/post-traumatic pain (TENS; temporary percutaneous PNS; auricular PENS) and acute primary headache disorders (sTMS; external trigeminal stimulation; noninvasive vagus nerve stimulation; remote electrical neuromodulation; cranial trigeminal + occipital stimulation). “Authorization type” reflects the primary U.S. regulatory pathway [510(k) vs De Novo]. Where applicable, the labeled duration of use (e.g., up to 3 days or up to 60 days) is noted. This table is not intended to be exhaustive for device families with multiple substantially equivalent clearances.
Use statements were summarized and harmonized from FDA marketing authorization documents for comparability and may not reproduce the exact original wording.