RELAXU-1— 510(k) K950411

Substantially Equivalent

Kinsei Shiatsu, Inc.

FDA 510(k) clearance K950411 for RELAXU-1, Substantially Equivalent on 1995-08-02. Applicant: Kinsei Shiatsu, Inc..

Clearance details

Applicant: Kinsei Shiatsu, Inc.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1995-01-31
Decision date: 1995-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Torrance, CA, 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.