SMART BTSNET8

GUDID B179SDXEVO1

SMART is a System for motion analysis, intended for the recording and analysis of human movement patterns in the. fields of rehabilitation, sports medicine, ergonomics, clinical research.

BTS SPA

Biomechanical function analysis system, motion-tracking

• Primary Device ID: B179SDXEVO1
• NIH Device Record Key: b61da719-6333-45e4-87c5-8990b0ca7f5a
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART
• Version Model Number: DX EVO
• Catalog Number: BTSNET8
• Company DUNS: 428484518
• Company Name: BTS SPA
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B179SDXEVO1 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131660

FDA Product Code

• LXJ: System, Optical Position/Movement Recording

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: 2023-09-14
• Device Publish Date: 2023-09-06

On-Brand Devices [SMART]

• B179SDX: SMART is a System for motion analysis, intended for the recording and analysis of human movement
• B179SDXEVO1: SMART is a System for motion analysis, intended for the recording and analysis of human movement
• B179SEVBUN260: SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for th
• B179SEVBUN090: SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for th
• B179SEVBUN050: SMART-DX EVO TVC camera component of SMART that is a System for motion analysis, intended for th