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FDA 510(k)

Manual Wheelchair (7101L, 7102LHD)

K-Number: K260121 · 2026-04-28

ApplicantFoshan Nanhai Hongchen Medical Equipment Co., Ltd.
Decision Date2026-04-28
Product CodeIOR
Advisory CommitteePM
DecisionSubstantially Equivalent

Device Summary

Manual Wheelchair (7101L, 7102LHD) is a medical device manufactured by Foshan Nanhai Hongchen Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-04-28 under approval number K260121. The device is classified under product code IOR. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Manual Wheelchair (7101L, 7102LHD)?

Manual Wheelchair (7101L, 7102LHD) is a medical device that received FDA 510(k) clearance on 2026-04-28. It is manufactured by Foshan Nanhai Hongchen Medical Equipment Co., Ltd.. The 510(k) number is K260121.

When was Manual Wheelchair (7101L, 7102LHD) approved by the FDA?

Manual Wheelchair (7101L, 7102LHD) received FDA 510(k) clearance on 2026-04-28, under approval number K260121.

What company makes Manual Wheelchair (7101L, 7102LHD)?

Manual Wheelchair (7101L, 7102LHD) is manufactured by Foshan Nanhai Hongchen Medical Equipment Co., Ltd..

What is the FDA product code for Manual Wheelchair (7101L, 7102LHD)?

The FDA product code for Manual Wheelchair (7101L, 7102LHD) is IOR.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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