SMART BTSSDX

GUDID B179SDX

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

BTS SPA

Biomechanical function analysis system, motion-tracking

• Primary Device ID: B179SDX
• NIH Device Record Key: 374b11e7-c7ef-4099-9dda-0a42be68c49b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SMART
• Version Model Number: DX
• Catalog Number: BTSSDX
• 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	B179SDX [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: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-02-12

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