MODIFIED STRESS MACHINE— 510(k) K873819

Substantially Equivalent

S.J.F., Inc.

FDA 510(k) clearance K873819 for MODIFIED STRESS MACHINE, Substantially Equivalent on 1988-01-22. Applicant: S.J.F., Inc..

Clearance details

Applicant: S.J.F., Inc.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1987-09-21
Decision date: 1988-01-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mars, PA, 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.