Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. FDA Record
- Latest inspection NAI · Dec 11, 2014
- No warning letters matched by name
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. has 0 FDA recalls, 2 inspections, 16 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd." is on file.
- Latest inspection
- Dec 11, 2014 · NAI
- Latest 510(k)
- Oct 28, 2026
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 11, 2026 (checked Nov 15, 2026, unchanged) | File dated Nov 10, 2026 | Current |
| 510(k) clearances | 16 | Nov 15, 2026 | File dated Nov 9, 2026 | Current |
| Inspections | 2 | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Dec 11, 2014 | Danyang City, China | Devices | No Action Indicated (NAI) | 3004111085 |
| Mar 22, 2012 | Danyang City, China | Devices | Voluntary Action Indicated (VAI) | 3004111085 |
- NAI
- No objectionable conditions or practices were found during the inspection.
- VAI
- Objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action.
- OAI
- Regulatory and/or administrative actions are recommended.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 3004111085 | Danyang City, China | 2 | Dec 11, 2014 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K260670 | YUWELL® Electronic Blood Pressure Monitor | Oct 28, 2026 |
| K261571 | Manual Wheelchair (H008, PCK7) | Aug 6, 2026 |
| K252779 | YUWELL® Electronic Blood Pressure Monitor (YE630CR) | Mar 5, 2026 |
| K253228 | YUWELL® Electronic Blood Pressure Monitor (YE650AR) | Feb 23, 2026 |
| K252805 | YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310) | Feb 17, 2026 |
| K242736 | Portable Oxygen Concentrator (Spirit-3) | Jun 5, 2025 |
| K250878 | YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107) | May 22, 2025 |
| K213825 | Oxygen Concentrator model 8F-3A, Oxygen Concentrator model 8F-5A | Apr 28, 2023 |
| K221372 | YUWELL Electronic Blood Pressure Monitor | Oct 17, 2022 |
| K212385 | YUWELL Finger Pulse Oximeter | Aug 16, 2022 |
| K203583 | YUWELL infrared ear thermometer: YHT101, YHT200 | May 20, 2021 |
| K201864 | YUWELL Infrared Thermometer | Dec 7, 2020 |
| K200939 | Electronic Blood Pressure Monitor | Aug 20, 2020 |
| K170605 | Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A… | Mar 27, 2018 |
| K120526 | YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR | Mar 8, 2012 |
| K083559 | YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B | Sep 4, 2009 |
Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. and the FDA: common questions
Has Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Jiangsu Yuyue Medical Equipment & Supply Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.?
The most recent FDA inspection on file ended Dec 11, 2014 at Danyang City, China and was classified NAI. FDA has 2 inspections of Jiangsu Yuyue Medical Equipment & Supply Co., Ltd. on file.
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