ORTHODERM CONVERTIBLE— 510(k) K894353

Substantially Equivalent

Health Products, Inc.

FDA 510(k) clearance K894353 for ORTHODERM CONVERTIBLE, Substantially Equivalent on 1989-08-09. Applicant: Health Products, Inc..

Clearance details

Applicant: Health Products, Inc.
Product code: Code IOQ
Advisory panel: Physical Medicine
Date received: 1989-07-14
Decision date: 1989-08-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOQ

product code IOQ

Malfunction: 676
Other: 5
Total: 681

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.