Kelvin Yang

FDA Filings

This page includes the latest FDA filings for Kelvin Yang. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3011564440
• FEI Number: 3011564440
• Name: Kelvin Yang
• Owner & Operator: Shenzhen OSTO Technology Company Limited
• Contact Address: No.43 Longfeng Road, Xinsheng Community, Longgang Street, Longgang District,; Shenzhen CN-44 Guangdong 518116 CN
• Official Correspondent:
  • Yang Lee
  • 86-755-29769546-x
• US Agent:
  • Kelvin Yang
  • 352 8712256
  • kelvin.usagent@gmail.com
• Importing Logistics Registration:
  • Importer: Universal Resources Co., Ltd.
  • Address: 2F-3, no.171, Songde Rd, XinYi District, Taipei City, Taiwan ; Taipei, 11085 TAIWAN
  • Email Address: Cassie.quan@glomed.info
  • Phone: 886 227260978
  • Importer Type: AGENT
  • Subdivision: TW-TPE
• Importing Logistics Registration:
  • Importer: World Depot Inc
  • Address: 1001 N Todd Ave, Azusa Ca ; Azusa, CA 91702 UNITED STATES
  • Email Address: Mark.zhou@worlddepot.com
  • Importer Type: AGENT
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10708 Bowmore Ct Douglass Hills, Kentucky, 40243, UNITED STATES; Douglass Hills, KY 40243 US
• Establishment Type: Foreign Private Label Distributor

• Registration Number: 3013553501
• FEI Number: 3013553501
• Name: Kelvin Yang
• Owner & Operator: Slinph Technologies Co., LTD
• Contact Address: 211-B,1970 Cultural and Creative Industrial Park,Minzhi Street,Longhua,; shenzhen CN-44 Guangdong 518107 CN
• Official Correspondent:
  • Kevin Zou
  • 86-0755-83461353-x
• US Agent:
  • Kelvin Yang
  • 352 8712256
  • kelvin.usagent@gmail.com
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 10708 Bowmore Ct ; Douglass Hills, KY 40243 US
• Establishment Type:
  • Manufacture Medical Device
  • Complaint File Establishment per 21 CFR 820.198

FDA Filings

Device Company	Device	Date
PMN K190467 | OAP Kelvin Yang [Slinph Technologies Co., LTD]	iHelmet Hair Growth System, model: LTD 88Lite	2020-01-11
PMN K190467 | OAP Kelvin Yang [Slinph Technologies Co., LTD]	iHelmet Hair Growth System, model: LTD 36Air	2020-01-11
PMN K190467 | OAP Kelvin Yang [Slinph Technologies Co., LTD]	iHelmet Hair Growth System, model: LTD 160Pro	2020-01-11
PMN K190673 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J	2019-12-20
PMN K190673 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Health Expert Electronic Stimulator-AST-300F, AST-300H, AST-300J	2019-12-20
PMN K182136 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)	2019-11-18
PMN K182136 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Intelligent Wireless Fitness Apparatus (Model: AST-301, AST-302, AST-303)	2019-11-18
PMN K172897 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Neck Care Therapy	2019-01-19
PMN K172897 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-905B	2019-01-19
PMN K172897 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-509B	2019-01-19
PMN K172897 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Neck Care Therapy	2019-01-19
PMN K172897 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-905B	2019-01-19
PMN K172897 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-509B	2019-01-19
PMN K172837 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Physiotherapy instrument	2019-01-19
PMN K172837 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-2011A, AST-2011B, AST-802B	2019-01-19
PMN K172837 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Physiotherapy instrument	2019-01-19
PMN K172837 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-2011A, AST-2011B, AST-802B	2019-01-19
PMN K172834 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Low-frequency Multi-function physiotherapy instrument	2019-01-19
PMN K172834 | NUH Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-603, AST-2012A, AST-2012B	2019-01-19
PMN K172834 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	Low-frequency Multi-function physiotherapy instrument	2019-01-19
PMN K172834 | NGX Kelvin Yang [Shenzhen OSTO Technology Company Limited]	AST-603, AST-2012A, AST-2012B	2019-01-19
PMN K162782 | OAP Kelvin Yang [Slinph Technologies Co., LTD]	IHelmet Hair Growth System	2017-04-20