Decompression of Choice

GUDID 00850020142392

PIVOTAL HEALTH SOLUTIONS, INC.

Programmable powered traction system
Primary Device ID00850020142392
NIH Device Record Key18e90002-987d-4d6a-bfd5-40f4973690b4
Commercial Distribution StatusIn Commercial Distribution
Brand NameDecompression of Choice
Version Model NumberE9022-e
Company DUNS826316098
Company NamePIVOTAL HEALTH SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850020142392 [Primary]

FDA Product Code

ITHEquipment, Traction, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-08-19
Device Publish Date2022-08-11

On-Brand Devices [Decompression of Choice]

00852753008938Tower decompression table, 230V
00852753008921tower decompression table, 115V
00852753008914swing arm decompression table, 230V
00852753008907Swing arm DOC table, 115V
00850020142408E9015-e
00850020142392E9022-e
00850020142385E9014-e
00850020142378E9011-e

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