AMPCARE Restorative Posture Device 50707

GUDID 00867786000231

Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.

AMPCARE, LLC

Cervicothoracic spine orthosis
Primary Device ID00867786000231
NIH Device Record Keya9264c10-9f9b-44fa-9f92-398f08dc0451
Commercial Distribution StatusIn Commercial Distribution
Brand NameAMPCARE Restorative Posture Device
Version Model NumberRPD
Catalog Number50707
Company DUNS013052325
Company NameAMPCARE, LLC
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Countertrue

Customer Support Contacts

Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com
Phone1-682-561-2444
Emailinfo@ampcarellc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100867786000231 [Primary]

FDA Product Code

IQFOrthosis, Cervical-Thoracic, Rigid

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-07-06
Device Publish Date2020-06-26

Devices Manufactured by AMPCARE, LLC

00867786000231 - AMPCARE Restorative Posture Device2020-07-06Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to enhance swallowing treatment by assisting with proper position of head and neck, maintaining placement and improving electrical conduction of E Series Electrodes and providing a resistive exercise protocol. For single patient use.
00867786000231 - AMPCARE Restorative Posture Device2020-07-06 Restorative Posture Device with pads. Orthosis device used in conjunction with AMPCARE's Effective Swallowing Protocol (ESP) to
00867786000200 - E Series2018-07-06 Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patien
10867786000214 - E Series2018-07-06 Self-adhering reusable stimulating electrodes that are intended to be used to apply electrical stimulation current to the patien

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