Who else makes this device?

Name: Amico Diagnostic, Inc.
Brand: Amico Diagnostic, Inc.

Ophthalmic › DiagnosticOphthalmoscope, Ac-Powered

Amico Diagnostic, Inc.

Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmoscope with AC power (DI 00697077003067) Aneroid and Blood…

Registry build 21.09.26

Diagnostic Station Ophthalmoscope & Otoscope LED, Spec Dispenser, Aneroid & Adult Cuff, Thermometer, Grey Wallboard Ophthalmoscope with AC power (DI 00697077003067) Aneroid and Blood Pressure Cuff (DI 00697077003074) Thermometer (DI 20884521008509) This is a test record to test our brand name and description fixes. This DI has not been applied to any Amico product.

7manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Jiangsu (5), Beijing (1), Jiangxi (1).

Chinese manufacturers registered for FDA product code HLI
Manufacturer	City	Province	Registered as	Device types
Beijing Hongdee Corporation	Beijing	Beijing	Private-label distributor	43
Lianyungang Tiannuo Optical Instrument Co., Ltd.	Lianyungang	Jiangsu	Contract manufacturer	31
Shanghai Link Instruments Co., Ltd.	Changzhou	Jiangsu	Manufacturer	21
Zumax Medical Co., Ltd.	Suzhou	Jiangsu	Contract manufacturer	19
Suzhou Raish Meditech Co., Ltd.	Suzhou	Jiangsu	Manufacturer	4
Jiang XI BIG Vision Medical Technology Co., Ltd.	Ganzhou	Jiangxi	Manufacturer	3
Robotrak Technologies Co., Ltd.	Nanjing	Jiangsu	Manufacturer	1

Record

Regulatory record for Amico Diagnostic, Inc.
Listed by	Amico Diagnostic Incorporated, Canada
FDA product code	HLI
Device type	Ophthalmoscope, Ac-Powered
Device class	Class 2
Regulation	21 CFR 886.1570
Establishment	Repacker / relabeller, Manufacturer, Exporter
Record published	2024-09-18
Record revised	2024-12-03 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	serial number
Distribution end date	2024-09-18

Catalogue Numbers

Catalogue numbers for Amico Diagnostic, Inc.
Catalogue number	Size	Status
TEST		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Welch Allyn, Inc.	Welch Allyn, Inc.	90
Amico Diagnostic Station	Amico Diagnostic Incorporated	55
iVue	Optovue, Inc.	27
Amico Diagnostic Wallboard	Amico Diagnostic Incorporated	19
Amico Diagnostic Rollstand	Amico Diagnostic Incorporated	14
iScan	Optovue, Inc.	7
zumax	Zumax Medical Co., Ltd.	6
Jedmed	Jedmed Instrument Company	3
RTVue XR Avanti	Optovue, Inc.	3
Amico Diagnostic Ophthalmoscope	Amico Diagnostic Incorporated	3
Laser Speckle Flowgraphy Lsfg-Navi	Softcare Co., Ltd.	2
Panoramic Ophthalmoscope	Optos Public Limited Company	1

Showing 12 of 46. All products under Ophthalmoscope, Ac-Powered

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K131939	2014-03-26

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.