Manual Wheelchair (H008, PCK7)— 510(k) K261571
Substantially EquivalentJiangsu Yuyue Medical Equipment & Supply Co., Ltd.
FDA 510(k) clearance K261571 for Manual Wheelchair (H008, PCK7), Substantially Equivalent on 2026-08-06. Applicant: Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.. Device class: 1.
Summary
Jiangsu Yuyue Medical Equipment & Supply filed a Manual Wheelchair in two listed models, H008 and PCK7, under product code IOR, mechanical wheelchairs.
Class I, 21 CFR 890.3850. Physical Medicine is both the classification panel and the review panel. It came in as a Traditional 510(k).
Yuyue filed from Danyang, Jiangsu, China. The substantially equivalent decision came 86 calendar days after receipt (May 12 to August 6, 2026).
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply 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
- Danyang Jiangsu, CN
Recent devices under product code IOR
view allMore clearances from Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
view all- K252779 — YUWELL® Electronic Blood Pressure Monitor (YE630CR)
- K253228 — YUWELL® Electronic Blood Pressure Monitor (YE650AR)
- K252805 — YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)
- K242736 — Portable Oxygen Concentrator (Spirit-3)
- K250878 — YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)
Adverse 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.