Monitor, Eye Movement

Which Manufacturers in China Make This?

2 manufacturers in China hold an FDA registration for this device type, based in Jiangsu.

66 Vision Tech Co., Ltd. Jiangsu
Taizhou City K&W International Trade Co., Ltd. Jiangsu

What Is FDA Product Code HLL?

Monitor, Eye Movement is FDA product code HLL, Class 2, 21 CFR 886.1510.

What Does It Take to Sell It in the United States?

A 510(k) premarket notification is required before it is sold in the United States: the applicant shows the device is substantially equivalent to one already on the market. The review can be done by an FDA-accredited third party, which is usually faster. No clearance under this code names a Chinese applicant.

A registration is not a clearance: the plants above are set up to make it, and the 510(k) it is sold under is held by whoever files it, often the brand.

Monitor, Eye Movement

Retitrack

Eye movement monitor

Monitor, Eye Movement

Saccadometer

Saccadometer Plus and Saccadometer Advanced measure horizontal eye movements and the timing of saccadic refixation responses to lateral visual stimuli. The FDA filing says measurements use…

Monitor, Eye Movement

Eli Ezer

2 catalogue numbers from EZ-OPH-1800/LL, listed by U.S. Ophthalmic, L.L.C., under Monitor, Eye Movement. 2 manufacturers in China are registered for this product code.

Monitor, Eye Movement

Which Manufacturers in China Make This?

What Is FDA Product Code HLL?

What Does It Take to Sell It in the United States?

Retitrack

Saccadometer

Eli Ezer

Where China Actually Supplies