DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000— 510(k) K944885

Name: FDA 510(k) clearance K944885
Creator: U.S. Food and Drug Administration
Published: 1995-02-14

Substantially Equivalent for Some Indications

Kolvin Industries , Ltd.

FDA 510(k) clearance K944885 for DH-1, DH-2, DH-3, DH-6, DH-68, DH-8, AMH-6, FM-10, FM-20, FM-30, FBM-1000, FBM-2000, Substantially Equivalent for Some Indications on 1995-02-14. Applicant: Kolvin Industries , Ltd.. Device class: 1.

Clearance details

Applicant: Kolvin Industries , Ltd.
Product code: Code ISA
Device class: Class 1
Regulation: 21 CFR 890.5660
Advisory panel: Physical Medicine
Date received: 1994-10-03
Decision date: 1995-02-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Kowloon, HK

Download summary PDF View on FDA.gov ↗

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K944884 — DR-3, DR-6, DR-68, DR-88, AMR-6, FR-22R, DR-22B1995-02-14

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.