FDA.reportPublic FDA data

Antalgic Trak

Primary DI
00860000487511
Brand
Antalgic Trak
Company
ANTALGIC-TRAK
Model
AT1000
Device description
Power Traction Equipment
Published
2018-10-30
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

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
K042482000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K042482000BASS ANTALGIC-TRAKTraction Masters, LLC2005-03-21ITH

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860000487511PackageGS11In Commercial Distribution
00860000487504PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860000487511008600004875118600004875110860000487511
00860000487504008600004875048600004875040860000487504

GMDN Terms#

Term, Definition table
TermDefinition
Static powered traction systemAn assembly of devices designed to apply continuous traction forces from a motor through harnesses typically attached to the cervical or lumbar vertebrae. It usually consists of a mains electricity (AC-powered) motor with a control unit to generate and regulate the mechanical forces, and a cord (e.g., braided nylon) clamped to harnesses to transmit the force. Adjustable spreader bars attached to the control unit may be used to vary the angle at which the cord applies traction. The assembly may be table/wall-mounted for horizontal cervical and lumbar traction, or vertical cervical traction. It is used to widen intervertebral spaces to treat prolapsed intervertebral disks and other disorders.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8007923575contact@antalgic-trak.com

Regulatory Flags#

DUNS number
043600853
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860000487573Antalgic TrakAT-24AF0008B2024-07-11
00860000487528Antalgic TrakAT-1002019-11-21
00860000487504Antalgic TrakAT10002018-10-30

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
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
00869444000218Accu Spina / Spina System CervicalNORTH AMERICAN MEDICAL CORPORATIONITH2016-09-24