XIAMEN CHINGSONG OPTICAL INDUSTRIAL CO., LTD.

FDA 510(k)

FDA Class 1 ·Ophthalmic

BIOFEEDBACK TMG1, 4, BIO1, PA1, 2, BA1/BA30

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE EMG1, EMG ULTRA LOW NOISE OPTI.

FDA 510(k)

FDA Class 2 ·Neurology

BASIC BIOFEEDBACK,TMG4.1, SA1/2, EEG4/5, IR RECEIV

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE ACCESS. PI1,2,3,4,5/LIGHT BAR

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK EEG1/2, EEG ULTRA LOW NOISE, SYC1

FDA 510(k)

FDA Class 2 ·Neurology

BIOFEEDBACK DEVICE TG3, TG4

FDA 510(k)

FDA Class 2 ·Neurology

High-speed Air Turbine Handpieces (SCHG01, SCHG03, SCHG18, SCHF19, SCHF22), Dental Low Speed Handpieces including Straight and Geared Angle Handpieces and Air Motors (Straight Handpieces: SCHD05-S, SCHD16-S, SCHD17-S, SCHD24-S, SCHD27-S Geared Angle Handpieces: SCHD05-C, SCHD06-C, SCHD16-C, SCHD17-C, SCHD24-C, SCHD27-C, SCHD29-S, SCHB4, SCHB5, SCHB20, SCHB64 Air Motors: SCHD16-M, SCHD17-M, SCHD24-M, SCHD27-M)

FDA 510(k)

FDA Class 1 ·Dental

Diazyme PLAC® Test for Lp-PLA2 Activity

FDA 510(k)

FDA Class 2 ·Immunology

Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay Analyzer

FDA 510(k)

FDA Class 2 ·Clinical Chemistry

Powered wheelchair (mobility robot) (M4, M4U)

FDA 510(k)

FDA Class 2 ·Physical Medicine

DR VISION NEO, DR VISION DOU

FDA 510(k)

FDA Class 2 ·Radiology

40CC PERCUTANEOUS FURL DOU. LUMEN BALLOON CATHETER

FDA 510(k)

FDA Class 2 ·Cardiovascular

MICRO MODE-TRANS ELECTRICAL NEURAL STIMULATOR

FDA 510(k)

FDA Class 2 ·Neurology

VINYL PATIENT EXAMINATION GLOVES

FDA 510(k)

FDA Class 1 ·General Hospital

SUNGLASSES

FDA 510(k)

FDA Class 1 ·Ophthalmic

PROSAFE SAFETY SYRINGE

FDA 510(k)

FDA Class 2 ·General Hospital

Topwide Surgical Face Mask

FDA 510(k)

FDA Class 2 ·General, Plastic Surgery

VINYL EXAMINATION GLOVES, PRE-POWDERED WITH VITAMIN E

FDA 510(k)

FDA Class 1 ·General Hospital

CLINI-DENT

FDA 510(k)

FDA Class 1 ·Dental