FDA.reportPublic FDA data

Decompression of Choice

Primary DI
00852753008914
Brand
Decompression of Choice
Company
PIVOTAL HEALTH SOLUTIONS, INC.
Model
E9014
Device description
swing arm decompression table, 230V
Published
2018-10-16
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Product Codes#

Code, Name table
CodeName
ITHEquipment, Traction, Powered

Product Code Classifications#

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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00852753008914PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00852753008914008527530089148527530089140852753008914

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

Regulatory Flags#

DUNS number
826316098
Device count
1
Serial number
true

Other Devices From This Company#

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00854798000793Torque TableTT10002026-05-27
00854798000526Elevating Hand Therapy TableHT1002026-03-27
00854798000533Elevating Hand Therapy TableHT2002026-03-27
00854798000571Elevating Hand Therapy TableHT9002026-03-27
00854798000588Elevating Hand Therapy TableHT17002026-03-27
00854798000601Elevating Hand Therapy TableHT19002026-03-27
00854798000656Elevating Hand Therapy TableREV1002026-03-27
00854798000663Elevating Hand Therapy TableREV2002026-03-27
00854798000670Elevating Hand Therapy TableREV9002026-03-27
00854798000748Elevating Hand Therapy TableREV17002026-03-27
00854798000762Elevating Hand Therapy TableREV19002026-03-27
00854798000786Portable Parallel BarsPTPB-10002026-03-27
00854798000465Parallel Bars Electric Platform MountEPB10080-NE2026-01-22
00854798000472Parallel Bars Electric Platform MountEPB10080B-NE2026-01-22
00854798000489Parallel Bars Electric Platform MountEPB10010-NE2026-01-22
00854798000496Parallel Bars Electric Platform MountEPB10010B-NE2026-01-22
00854798000502Parallel Bars Electric Platform MountEPB10012-NE2026-01-22
00854798000519Parallel Bars Electric Platform MountEPB10012B-NE2026-01-22
00850020142446AE Elevating Treatment TableA4201-EL2025-08-12
00854798000298Parallel Bars Electric Platform MountEPB100802025-05-09

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
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