Ergostyle ES2000

GUDID 00850008449796

PIVOTAL HEALTH SOLUTIONS, INC.

Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered Traction table, line-powered
Primary Device ID00850008449796
NIH Device Record Keydc44fab0-f3f4-4a42-9db3-4145410628df
Commercial Distribution StatusIn Commercial Distribution
Brand NameErgostyle ES2000
Version Model NumberES9320
Company DUNS826316098
Company NamePIVOTAL HEALTH SOLUTIONS, INC.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100850008449796 [Primary]

FDA Product Code

INQTable, Powered

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-09-06
Device Publish Date2021-08-27

On-Brand Devices [Ergostyle ES2000]

00850008449802ES9330
00850008449796ES9320
00850008449789ES9310
00850008449772ES9300

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