Mytech Technology Co., Ltd. FDA Record
- Latest inspection NAI · Dec 9, 2011
- No warning letters matched by name
Mytech Technology Co., Ltd. has 0 FDA recalls, 1 inspection, 4 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Mytech Technology Co., Ltd." is on file.
- Latest inspection
- Dec 9, 2011 · NAI
- Latest 510(k)
- Aug 22, 2006
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 4 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 1 | Nov 14, 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 9, 2011 | Xin Bei Shi, Taiwan | Devices | No Action Indicated (NAI) | 3003876756 |
- 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 3003876756 | Xin Bei Shi, Taiwan | 1 | Dec 9, 2011 |
Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K061959 | MYTECH / HAPPY LIFE / MAXIAIDS ARM BLOOD PRESSURE MONITOR, HPL-301, HPL-302, HPL-310, 180310 | Aug 22, 2006 |
| K041228 | MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODEL HPL-200 | May 17, 2004 |
| K030221 | MYTECH / HAPPY LIFE BLOOD PRESSURE MONITOR | Jul 25, 2003 |
| K030561 | MYTECH/HAPPY LIFE BLOOD PRESSURE MONITOR, MODELS HPL-100 AND HPL-100A | May 9, 2003 |
Mytech Technology Co., Ltd. and the FDA: common questions
Has Mytech Technology Co., Ltd. received an FDA warning letter?
No FDA warning letter addressed to the name "Mytech Technology 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 Mytech Technology Co., Ltd. received an FDA Form 483?
FDA has not published a Form 483 for "Mytech Technology Co., Ltd." in its reading room. FDA publishes some Form 483s, not all of them.
When did the FDA last inspect Mytech Technology Co., Ltd.?
The most recent FDA inspection on file ended Dec 9, 2011 at Xin Bei Shi, Taiwan and was classified NAI. FDA has 1 inspection of Mytech Technology Co., Ltd. on file.
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