Wenzhou Bokang Instrument Co., Ltd.
This firm is named on 2 FDA import alerts in China. Shipments from a listed firm may be detained at the port without physical examination. The oldest listing dates to 14 November 2017, the newest to 17 April 2019.
- 2import alerts now
- 8years since the first listing
- 0listings come off
- 30 Augustcopy checked, 2026
Every alert naming this firm
Source: FDA import alerts, mirrored 30 August 2026 · newest listing first
| Alert | Subject | Country | Listed since |
|---|---|---|---|
| 89-08 | Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)79K--CY | China | 17 April 20197 yr |
| 89-17 | Medical Devices That Appear to Be Adulterated Because Their Quality Falls Below That Which They Purport or Are Represented to Possess74D--XN · 74D--XQ · 74D--XQ · 74D--XQ | China | 14 November 20178 yr |
Product classes covered
A listing does not cover everything the factory makes — it covers the FDA product codes named on the alert. These are the codes attached to this firm, with the class FDA prints for each.
| Code | Product class |
|---|---|
| 74D--XN | System, Measurement, Blood-Pressure, Non-Invasive |
| 74D--XQ | Cuff, Blood-Pressure |
| 79K--CY | Tourniquet, Pneumatic |
Why this matters under FSVP
If you import this firm's food into the United States, the FSVP rule makes you re-evaluate the supplier when new information comes to light about its performance. An import alert listing is exactly that kind of information. What FSVP requires and where this fits.
This page exists because the firm was on more than one alert when we first saw it, on 30 August 2026. It stays even after the listings come off, because FDA does not publish removals. What moved lately · check another supplier.