SpineMED Decompression System

Basic Information

• Brand Name: SpineMED Decompression System
• Primary DI: M767S200E0
• Version / Model: S200E
• Company Name: Universal Pain Technology Canada Inc
• Labeler DUNS: 203020057
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-30
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: d597b27a-cb0f-4aca-8d08-192a4da26a6b

Device Description

SpineMED S200E Express Decompression System Lumbar Only

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
ITH	Equipment, Traction, Powered	Physical Medicine	890.5900	2

GMDN Terms

Code	Name	Definition	Implantable	Status
61867	Programmable powered traction system	An assembly of devices intended to generate and apply computer-controlled horizontal cervical and/or lumbar traction distraction forces, with the ability to target specific spinal segments, for non-surgical decompression of intervertebral discs and/or widening of intervertebral spaces to treat prolapsed intervertebral discs and related disorders. It typically consists of a mains electricity (AC-powered) motor with a computerized control unit to generate and regulate the mechanical forces, an adjustable table and attachments (e.g., cord or pulley) to transmit traction forces to the harnesses and/or the table, with ability to tilt a portion of the table to adjust distraction force vectors.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	M767S200E0	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K051013	000