TISSUE PULSATOR— 510(k) K780683

Substantially Equivalent

Pulsator Corp.

FDA 510(k) clearance K780683 for TISSUE PULSATOR, Substantially Equivalent on 1978-05-03. Applicant: Pulsator Corp..

Clearance details

Applicant: Pulsator Corp.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1978-04-24
Decision date: 1978-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code ISA

product code ISA

Death: 3
Other: 1
Total: 4

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.