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.
Clearance details
- Applicant
- Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.
- Product code
- 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
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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.