510(k) K944885— 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

Kolvin Industries , Ltd.

Clearance details

Applicant: Kolvin Industries , Ltd.
Product code: Code ISA
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

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.