HUBANG, MODEL HBL13/HBG12-S— 510(k) K083044

Substantially Equivalent

Shanghai Hubang Medical Appliances Co., Ltd.

FDA 510(k) clearance K083044 for HUBANG, MODEL HBL13/HBG12-S, Substantially Equivalent on 2008-12-12. Applicant: Shanghai Hubang Medical Appliances Co., Ltd..

Clearance details

Applicant: Shanghai Hubang Medical Appliances Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2008-10-14
Decision date: 2008-12-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Banqiao, TW

Download summary PDF View on FDA.gov ↗

Adverse events under product code IOR

product code IOR

Death: 10
Injury: 232
Other: 2
Total: 244

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.