FDA.reportPublic FDA data

REPEX

Primary DI
00860001452518
Brand
REPEX
Company
HILL LABORATORIES CO.
Model
REPEX
Published
2020-02-04
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Single use
true

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
K043239000
K925271000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K043239000HEALTHSTAR ELITEHill Laboratories Co.2004-12-22ITH
K925271000REPEX-REPEATED ENDRANGE PASSIVE EXERCISE MACHINERepex Intl., Inc.1993-03-31BXB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860001452518PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860001452518008600014525188600014525180860001452518

GMDN Terms#

Term, Definition table
TermDefinition
Body arch traction tableA fixed framework table designed to support the body of a patient and provide traction for the back muscles and spine by flexing the patient into a reverse supine body arch. The patient locks their feet behind a cross-member and bends backward over the curvature of the table to flex the vertebrae of the spine, relieving spinal compression, relaxing the shoulders, neck, and back muscles, whilst stretching and strengthening the core muscles of the body. This device can be used in a healthcare facility or in the home to assist patients eliminate/alleviate back pain.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
002326585
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850058158051HA90PHA90P2023-10-24
00850058158075HA90PTHA90PT2023-10-24
00850058158105HI-LOHI-LO2023-10-24
00850058158136Rath Mechanical Extension TableRath Mechanical2023-10-24
00860001452556Spinalight, IncSpinalight C-10002023-10-24
00850058158037HA90LBC CounterstrainHA90LBC Counterstrain2023-10-23
00860001452587HA90CHA90C2023-10-23
00860001452594HA90HA902023-10-23
00860011173601HA90EHA90E2023-10-23
00860001452532HF54, HorizonHF54, Horizon2020-02-04
00850058158143The SAVE ProgramSAVE Motion Chair2024-03-11
00860011173649Advanced Chiropractic Equipment LLCHA90RD2023-10-23
00850058158006HA90RHA90R2023-10-24
00850058158068HA90PHHA90PH2023-10-24
00850058158082HA90VHA90V2023-10-24
00850058158099HA90WHA90W2023-10-24
00850058158112Massage TableMassage Table2023-10-24
00850058158129PT Tilt TablePT Tilt Table2023-10-24
00850058158013HA90DHA90D2023-10-23
00850058158020HA90LBHA90LB2023-10-23

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