SENSORY ROLLER MASSAGER— 510(k) K833090

Substantially Equivalent

Maddak, Inc.

FDA 510(k) clearance K833090 for SENSORY ROLLER MASSAGER, Substantially Equivalent on 1983-10-14. Applicant: Maddak, Inc..

Clearance details

Applicant: Maddak, Inc.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1983-09-12
Decision date: 1983-10-14
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.