FDA.reportPublic FDA data

SpineMED S200U Ultra Decompression System

Primary DI
M767S200U1
Brand
SpineMED S200U Ultra Decompression System
Company
Universal Pain Technology Canada Inc
Model
S200U
Device description
SpineMED S200U Ultra Decompression System Lumbar Only
Published
2017-07-07
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
ITHEquipment, Traction, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
ITHEquipment, Traction, PoweredPhysical Medicine2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K051013000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K051013000SPINEMED S200B/S200CCert Health Sciences, LLC2005-04-27ITH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M767S200U1PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Programmable powered traction systemAn 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-866-990-4444info@spinemed.com

Regulatory Flags#

DUNS number
203020057
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
M767S200UC1SpineMED Decompression SystemS200UC2017-07-07
M767S200B1SpineMED Decompression SystemS200B2016-06-30
M767S200C1SpineMED Decompression SystemS200C2016-06-30
M767S200E1SpineMED Decompression SystemS200E2016-06-30
M767S200EC1SpineMED Decompression SystemS200EC2016-06-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860000487573Antalgic TrakANTALGIC-TRAKITH2024-07-11
04719871180297EverywayEVERYWAY MEDICAL INSTRUMENTS CO., LTD.ITH2023-08-24
04053815083344clTracZimmer MedizinSysteme GmbHITH2023-06-05
00850020142378Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00850020142385Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00850020142392Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00850020142408Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2022-08-11
00860001452501Hill DT SolutionsHILL LABORATORIES CO.ITH2020-02-04
00860001452518REPEXHILL LABORATORIES CO.ITH2020-02-04
00860000487528Antalgic TrakANTALGIC-TRAKITH2019-11-21
B727M100Extentrac EliteAdvanced Back Technologies IncITH2019-11-06
00860000487504Antalgic TrakANTALGIC-TRAKITH2018-10-30
00860000487511Antalgic TrakANTALGIC-TRAKITH2018-10-30
00852753008907Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00852753008914Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00852753008921Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00852753008938Decompression of ChoicePIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00852753008945iTracPIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00852753008952iTracPIVOTAL HEALTH SOLUTIONS, INC.ITH2018-10-16
00888912423069CHATTANOOGADJO, LLCITH2017-11-16
00888912438148CHATTANOOGADJO, LLCITH2017-11-16
00888912438360CHATTANOOGADJO, LLCITH2017-11-16
00888912442411CHATTANOOGADJO, LLCITH2017-11-16
00888912443289CHATTANOOGADJO, LLCITH2017-11-16
00888912443722CHATTANOOGADJO, LLCITH2017-11-16
M767S200UC1SpineMED Decompression SystemUniversal Pain Technology Canada IncITH2017-07-07
10660584000321Dynatron TX900+ Traction SystemDynatronics CorporationITH2016-09-24
10660584000451Dynatron SmarTRAC Dynatronics CorporationITH2016-09-24
04983087007932TM-400ITO CO., LTD.ITH2016-09-24
00869444000218Accu Spina / Spina System CervicalNORTH AMERICAN MEDICAL CORPORATIONITH2016-09-24