Merits Health Products Co., Ltd. FDA Record
- Latest inspection NAI · Apr 2, 2026
- Last warning letter 2011
Merits Health Products Co., Ltd. has 3 FDA recalls, 7 inspections, 31 510(k) clearances and 1 compliance action on record. FDA has issued 1 warning letter to Merits Health Products Co., Ltd., the most recent on Nov 29, 2011.
- Latest recall
- Z-1505-2021 · Class II · Apr 1, 2021
- Latest inspection
- Apr 2, 2026 · NAI
- Latest 510(k)
- Mar 18, 2022
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 3 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 31 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 7 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 1 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
FDA record by year
Merits Health Products Co., Ltd.: FDA inspections per year
| Year | Inspections | OAI | Warning letters | Recall records | Class I |
|---|---|---|---|---|---|
| 2026 | 1 | 0 | 0 | 0 | 0 |
| 2025 | 1 | 0 | 0 | 0 | 0 |
| 2024 | 0 | 0 | 0 | 0 | 0 |
| 2023 | 1 | 0 | 0 | 0 | 0 |
| 2022 | 1 | 0 | 0 | 0 | 0 |
| 2021 | 0 | 0 | 0 | 2 | 0 |
| 2020 | 0 | 0 | 0 | 1 | 0 |
| 2019 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 1 | 0 | 0 | 0 | 0 |
| 2017 | 0 | 0 | 0 | 0 | 0 |
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Merits Health Products Co., Ltd. FDA Warning Letters
| Issued | Subject | Issuing office | Close-out letter |
|---|---|---|---|
| Nov 29, 2011 · Record page |
Recent recalls
| Number | Class | Product | Date |
|---|---|---|---|
| Z-1505-2021 | Class II | Scooter | Apr 1, 2021 |
| Z-1504-2021 | Class II | Power Wheelchair | Apr 1, 2021 |
| Z-1632-2020 | Class II | Merits E604 Pilot Navigator Stairlift - Product Usage: To transport patients up stairs. | Mar 2, 2020 |
Recent FDA inspections
| Date | Site | Product | Classification | FEI |
|---|---|---|---|---|
| Apr 2, 2026 | Taichung, Taiwan | Devices | No Action Indicated (NAI) | 1000334118 |
| Feb 27, 2025 | Fort Myers, FL | Devices | Voluntary Action Indicated (VAI) | 1000221992 |
| Apr 27, 2023 | Taichung, Taiwan | Devices | No Action Indicated (NAI) | 1000334118 |
| Dec 6, 2022 | Fort Myers, FL | Devices | No Action Indicated (NAI) | 1000221992 |
| Mar 9, 2018 | Fort Myers, FL | Devices | Voluntary Action Indicated (VAI) | 1000221992 |
| Nov 7, 2012 | Taichung, Taiwan | Devices | No Action Indicated (NAI) | 1000334118 |
| Jul 14, 2011 | Taichung, Taiwan | Devices | Official Action Indicated (OAI) | 1000334118 |
- 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.
Compliance Actions
FDA's compliance actions data lists 1 compliance action under Merits Health Products Co., Ltd.: warning letters, injunctions and seizures. None came from FDA's Center for Tobacco Products.
FDA-inspected facilities
| Facility | Location | Inspections | Latest |
|---|---|---|---|
| FEI 1000334118 | Taichung, Taiwan | 4 | Apr 2, 2026 |
| FEI 1000221992 | Fort Myers, FL | 3 | Feb 27, 2025 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K220529 | Merits P335 Powered Wheelchair | Mar 18, 2022 |
| K142912 | Merits Yoga Power Scooter, S542 | Jun 23, 2015 |
| K142162 | MERITS TRANSFORMER POWER SCOOTER, S941 | May 1, 2015 |
| K122357 | MERITS MODEL P322FWD POWERED WHEELCHAIR | Jan 9, 2013 |
| K113577 | MERITS MODEL R SERIES POSITIONING SYSTEM FOR POWERED WHEELCHAIR | May 8, 2012 |
| K092859 | MERITS MODEL N SERIES NEBULIZER COMPRESSORS | Jul 2, 2010 |
| K091716 | MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY | Apr 2, 2010 |
| K073110 | MERITS E600 SERIES STAIR LIFT | Feb 6, 2008 |
| K073513 | MERITS E700 PORCE LIFT | Jan 14, 2008 |
| K053490 | MERITS HEALTH PRODUCTS PORTABLE NEBULIZER | Jul 24, 2006 |
| K053230 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | May 16, 2006 |
| K053229 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Mar 23, 2006 |
| K060212 | MERITS MODEL E SERIES LIFT CHAIRS | Mar 7, 2006 |
| K052650 | PIONEER U601 SERIES ASPIRATOR | Nov 4, 2005 |
| K050430 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATOR | Aug 4, 2005 |
| K041823 | PIONEER U121 SERIES CPAP | May 10, 2005 |
| K014301 | MODIFICATION TO MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Feb 11, 2002 |
| K013788 | TRAVEL EASE ELECTRIC SCOOTER, MODEL PIONEER 5 | Dec 11, 2001 |
| K012802 | MP3CF ELECTRIC WHEELCHAIR | Sep 18, 2001 |
| K011844 | MERITS HEALTH PRODUCTS OXYGEN CONCENTRATORS | Aug 28, 2001 |
Merits Health Products Co., Ltd. and the FDA: common questions
Has Merits Health Products Co., Ltd. received an FDA warning letter?
Yes. FDA has issued 1 warning letter to Merits Health Products Co., Ltd.. The most recent is dated Nov 29, 2011.
Has Merits Health Products Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Merits Health Products Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Merits Health Products Co., Ltd.?
The most recent FDA inspection on file ended Apr 2, 2026 at Taichung, Taiwan and was classified NAI. FDA has 7 inspections of Merits Health Products Co., Ltd. on file, 1 of them classified OAI (official action indicated).
Has Merits Health Products Co., Ltd. had an FDA recall?
Yes. Merits Health Products Co., Ltd. has 3 FDA recalls on record. The most recent started Apr 1, 2021.
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