Aneuvo · Class II · Cleared Mar 27, 2026
| K-number | K252893 |
| Device name | ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013) |
| Applicant | Aneuvo |
| Product code | SDO |
| Device class | Class II |
| Decision date | Mar 27, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 890.5851 |
The ExaStim Stimulation System is a portable, battery-operated medical device that delivers transcutaneous electrical stimulation to the spinal cord via a 16-channel electrode pad. It is indicated to improve hand sensation and strength in individuals aged 18-75 with chronic, incomplete spinal cord injury when used with functional task practice.
The ExaStim system uses biphasic rectangular waveform stimulation at 1-100 Hz frequency with 0.3-1 ms pulse width, delivering up to 150 mA and 75 V. Key differences from the predicate (ARCEX) include lower maximum current (150 vs 250 mA), different voltage specifications, expanded output channels (up to 16 vs 4), and a proprietary multi-electrode pad instead of single electrodes. Both use surface electrical stimulation and the same return electrodes.
IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10, IEC 62366-1, ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-23, ANSI C63.27, ASTM D4332, and ASTM D4169-22.
Non-clinical testing and technological comparison demonstrate substantial equivalence because both devices use the same mode of action (transcutaneous electrical stimulation via surface electrodes), have identical indications for use (improving hand sensation and strength in incomplete spinal cord injury), and minor differences in design specifications and stimulation parameters do not significantly affect safety and effectiveness as supported by comprehensive performance testing.
View the full FDA submission: accessdata.fda.gov