INSIGNIA

GUDID 16970729041749

Zhongshan Transtek Electronics Co.,Ltd

Bioelectrical body composition analyser

• Primary Device ID: 16970729041749
• NIH Device Record Key: 6aa58e17-40db-4384-b0e5-ab517e9b3752
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: INSIGNIA
• Version Model Number: NS-GLSBFSCW1
• Company DUNS: 544411562
• Company Name: Zhongshan Transtek Electronics Co.,Ltd
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• 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: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	16970729041749 [Primary]

FDA Product Code

• PUH: Analyzer, Body Composition, Exempt

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: 2020-11-06
• Device Publish Date: 2020-10-29

Devices Manufactured by Zhongshan Transtek Electronics Co.,Ltd

• 06970729040202 - CADENCE: 2025-07-29
• 06970729040080 - TeleRPM™: 2025-02-14 TeleRPM Body Scale
• 06970729040226 - TeleMate Health &TeleRPM: 2024-04-16 TeleRPM Body Scale
• 06970729040165 - EZFAST: 2023-07-19
• 06970729040097 - Remotecare4U: 2023-05-08
• 06970729040103 - TeleRPM™: 2023-05-08
• 16970729040001 - Veris Health: 2022-12-07
• 16970729040018 - TeleRPM™: 2022-12-07