Xiamen J Brace Medical Equipment Co L T D

FDA Filings

This page includes the latest FDA filings for Xiamen J Brace Medical Equipment Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3008381107
• FEI Number: 3008381107
• Name: John S Samorajczyk
• Owner & Operator: Xiamen J-Brace Medical Equipment Co., Ltd.
• Contact Address: 2F79# Tongan Park Tongan Industrial Concnetration Area; Xiamen CN-NOTA 361009 CN
• Official Correspondent:
  • Li Zemei
  • 86-592-7205951-x
• US Agent:
  • John S Samorajczyk
  • Samorajczyk Regulatory Consultants, LLC
  • 727 3678906
  • 727 3673212
  • jsamo@prodigy.net
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 5414 Leilani Drive ; Saint Petersburg, FL 33706 US
• Establishment Type:
  • Manufacture Medical Device
  • Repack or Relabel Medical Device

FDA Filings

Device Company	Device	Date
MSH John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	surgical masks, respirators	2020-03-25
BXB John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	ANKLE MOTION	2020-03-13
OHI John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Foot Drop Orthosis	2018-03-20
ITQ John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Knee Brace	2018-03-20
IQI John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Shoulder Braces Supports	2018-03-20
IQE John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Lumbar Support	2018-03-20
IOY John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	elbow and arm braces supports	2018-03-20
IQM John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Dorsal Night Splint	2014-01-13
MRI John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	J-Brace, Various Shoulder Braces, K	2010-04-28
KTD John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	J-Brace Waist Braces, Lumbar/Spinal	2010-04-28
ITW John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Ankle Brace, Foot Brace,	2010-04-28
IQK John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	J-Brace and various neck braces	2010-04-28
ILI John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Wrist Brace,	2010-04-28
ILI John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	J-Brace arm brace, elbow brace, wri	2010-04-28
ILH John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Hand Brace	2010-04-28
ILH John S Samorajczyk [Xiamen J-Brace Medical Equipment Co., Ltd.]	Finger Brace, Finger Splint	2010-04-28