FDA.reportPublic FDA data

SpineMED Decompression System

Primary DI
M767S200B1
Brand
SpineMED Decompression System
Company
Universal Pain Technology Canada Inc
Model
S200B
Device description
SpineMED S200B Lumbar Decompression System
Published
2016-06-30
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
M767S200B1PrimaryHIBCC0

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
M767S200C1SpineMED Decompression SystemS200C2016-06-30
M767S200E1SpineMED Decompression SystemS200E2016-06-30
M767S200EC1SpineMED Decompression SystemS200EC2016-06-30
M767S200U1SpineMED S200U Ultra Decompression SystemS200U2017-07-07

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
M767S200U1SpineMED S200U Ultra 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