510(k) K252893
- Device
- ExaStim® Stimulation System (EXA-001); ExaStim® Stimulation System (EXA-011); ReCure® Electrode Pad (PAD-003); ReCure® Electrode Pad (PAD-013)
- Applicant
- Aneuvo
- 510(k) number
- K252893
- Product code
- SDO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-03-27
- Date received
- 2025-09-11
- Regulation
- 890.5851
- Classification name
- Transcutaneous Electrical Spine Stimulator To Improve Skeletal Muscle Strength And Sensation
- Medical specialty
- Physical Medicine
- Review panel
- Physical Medicine
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- Amelia Striegel
- Address
- 10940 Wilshire Blvd. Suite 2030 Los Angeles CA US 90024 90024
FDA Registration Numbers#
- 3034209955
- 3045321552
- 3034211447
- 3027062639