Manual Wheelchair (7101L, 7102LHD)— 510(k) K260121
Substantially EquivalentFoshan Nanhai Hongchen Medical Equipment Co., Ltd.
FDA 510(k) clearance K260121 for Manual Wheelchair (7101L, 7102LHD), Substantially Equivalent on 2026-04-28. Applicant: Foshan Nanhai Hongchen Medical Equipment Co., Ltd.. Device class: 1.
Summary
Foshan Nanhai Hongchen Medical Equipment's Manual Wheelchair comes in two models, 7101L and 7102LHD, filed under product code IOR (Wheelchair, Mechanical). The record doesn't say how the two differ.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Foshan Nanhai Hongchen Medical Equipment filed from Foshan, China. The decision came 103 calendar days after FDA received it (January 15 to April 28, 2026).
Clearance details
- Applicant
- Foshan Nanhai Hongchen Medical Equipment Co., Ltd.
- Product code
- Product code IOR
- Device class
- Class 1
- Regulation
- 21 CFR 890.3850
- Advisory panel
- Physical Medicine
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Foshan, CN
Recent devices under product code IOR
view allAdverse events under product code IOR
product code IOR- Death
- 10
- Injury
- 232
- Other
- 2
- Total
- 244
Source: openFDA MAUDE database, through . 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.