FDA applicant
Sound Health Systems, Inc.
FDA records 2 decisions for Sound Health Systems, Inc. (Los Altos, CA) from 2023 to 2025: 1 510(k) clearance and 1 De Novo grant. All are in product code QZC (External Mechanical Stimulator For The Relief…). Its devices cite 1 predicate, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Sound Health Systems, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like Sound Health Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) ReportOther applicant names beginning “Sound”
FDA records each applicant name separately; these may or may not be the same firm.