FOTOSY

GUDID 16927709403431

Shenzhen Jamr Medical Technology Co., Ltd.

Automatic-inflation electronic sphygmomanometer, portable, arm/wrist

• Primary Device ID: 16927709403431
• NIH Device Record Key: 8c87a846-474a-41ca-bfde-6d8fc3d5ed88
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: FOTOSY
• Version Model Number: W02
• Company DUNS: 421350239
• Company Name: Shenzhen Jamr Medical Technology Co., Ltd.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: true

Device Identifiers

Device Issuing Agency	Device ID
GS1	06927709403434 [Primary]
GS1	16927709403431 [Package]; Contains: 06927709403434; Package: [60 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220651

FDA Product Code

• DXN: System, Measurement, Blood-Pressure, Non-Invasive

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-08-05
• Device Publish Date: 2025-07-28

On-Brand Devices [FOTOSY]

• 06927709403083: W1101L
• 16927709402991: BA31
• 16927709402984: BN1WC
• 16927709403431: W02