Merits Model R106/R136 Rehab Wheelchair— 510(k) K170517

Substantially Equivalent

Merits Healthcare Industries (Suzhou) Co., Ltd.

FDA 510(k) clearance K170517 for Merits Model R106/R136 Rehab Wheelchair, Substantially Equivalent on 2017-11-16. Applicant: Merits Healthcare Industries (Suzhou) Co., Ltd..

Clearance details

Applicant: Merits Healthcare Industries (Suzhou) Co., Ltd.
Product code: Code IOR
Advisory panel: Physical Medicine
Date received: 2017-02-21
Decision date: 2017-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taicang City, CN

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.