VIBRA-SURGE SYSTEM MODEL VS2120— 510(k) K971533

Substantially Equivalent

Sonics & Materials, Inc.

FDA 510(k) clearance K971533 for VIBRA-SURGE SYSTEM MODEL VS2120, Substantially Equivalent on 1997-07-25. Applicant: Sonics & Materials, Inc..

Clearance details

Applicant: Sonics & Materials, Inc.
Product code: Code LFL
Advisory panel: Unknown
Date received: 1997-04-28
Decision date: 1997-07-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danbury, CT, US

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Adverse events under product code LFL

product code LFL

Death: 29
Injury: 1,046
Malfunction: 21,642
Total: 22,717

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.