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

Name: FDA 510(k) clearance K931636
Creator: U.S. Food and Drug Administration
Published: 1994-03-28

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.. Device class: 1.

Clearance details

Applicant: Fairform Mfg., Co., Ltd.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
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

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISA

view all

K243488 — VMAT PRO2025-02-06
K240358 — ShockPhysio Mobile (model SW3200 Basic)2024-06-05
K221865 — BTL-0942023-04-14
K210166 — Omnispec ED10002023-01-27
K213120 — OW100S (model OW100S-US)2022-10-12

More clearances from Fairform Mfg., Co., Ltd.

view all

K931637 — A013 FEMI-FORM FACIAL MASSAGER1994-03-28
K931638 — FO96 HANDY MASSAGER1994-03-28
K931639 — F183 AC-MINI MASSAGER WITH UL APROVED ADAPTOR1994-03-28
K931640 — AO11 BODY MASSAGER1994-03-28
K920644 — F499 DELUXE ELECTRIC TOOTH BRUSH W/ STAND1992-05-29

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.