PERSONAL BODY MASSAGER, MODELS 1605 & 1606— 510(k) K912822

Substantially Equivalent

Raymond Industrial, Ltd.

FDA 510(k) clearance K912822 for PERSONAL BODY MASSAGER, MODELS 1605 & 1606, Substantially Equivalent on 1992-02-11. Applicant: Raymond Industrial, Ltd..

Clearance details

Applicant: Raymond Industrial, Ltd.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1991-06-25
Decision date: 1992-02-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Norwalk, CT, 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.