FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER— 510(k) K931636

Substantially Equivalent

Fairform Mfg., Co., Ltd.

FDA 510(k) clearance K931636 for FO18/FO98 SCRUBOFLEX SHOWERPROOF BRUSH MASSAGER, Substantially Equivalent on 1994-03-28. Applicant: Fairform Mfg., Co., Ltd..

Clearance details

Applicant: Fairform Mfg., Co., Ltd.
Product code: Code ISA
Advisory panel: Physical Medicine
Date received: 1993-03-31
Decision date: 1994-03-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Po Kong, Kowloon, HK

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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.