MULTIPLE— 510(k) K853297

Name: FDA 510(k) clearance K853297
Creator: U.S. Food and Drug Administration
Published: 1985-11-05

Substantially Equivalent

Sun Air, Inc.

FDA 510(k) clearance K853297 for MULTIPLE, Substantially Equivalent on 1985-11-05. Applicant: Sun Air, Inc.. Device class: 1.

Clearance details

Applicant: Sun Air, Inc.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1985-08-06
Decision date: 1985-11-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Recent devices under product code ISA

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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

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.