SEC — Wearable Fall Injury Prevention Device Class II
FDA product code SEC covers "Wearable Fall Injury Prevention Device", a Class II medical device regulated under 21 CFR 890.3780. Submissions are reviewed by the Physical Medicine panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- SEC
- Device Class
- Class II
- Regulation Number
- 890.3780
- Submission Type
- Review Panel
- PM
- Medical Specialty
- Physical Medicine
- Implant
- No
Definition
A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| DEN240021 | active protective technologies | Tango® Belt (Model SAS-001-01 (XS); Model SAS-001-02 (S); Model SAS-001-03 (M); | April 9, 2025 |