DEVICE: QB1 NMES System (00854816006530)

Device Identifier (DI) Information

QB1 NMES System
QB-1000-044
In Commercial Distribution
QB-1000-044
Motive Health, Inc.
00854816006530
GS1

1
035596579 *Terms of Use
QB1 NMES System; X-LARGE, REGULAR, LEFT
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Device Characteristics

Labeling does not contain MRI Safety Information
No
Yes
Yes
Yes
No
Yes
No
No

GMDN

[?]

GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. The copyright and database rights in the original GMDN materials are owned by The GMDN Agency Ltd 2005-2023. Used under licence from The GMDN Agency Ltd.

GMDN Term Code GMDN Term Name GMDN Term Definition GMDN Term Status [?] Implantable?
46573 Physical therapy transcutaneous neuromuscular electrical stimulation system
An electrically-powered device assembly intended to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy [neuromuscular electrical stimulation (NMES)/electronic muscle stimulation (EMS)]; it may in addition be intended for transcutaneous electrical nerve stimulation (TENS) to treat pain, and/or electroacupuncture. It includes an electric current pulse generator and noninvasive electrodes; it is not intended for tremor suppression. Clinical applications typically include relaxation/re-education of muscles, prevention of muscle atrophy, and improvement of blood circulation.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
IPF Stimulator, Muscle, Powered
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Storage Environment Temperature: between -13 and 158 Degrees Fahrenheit
Handling Environment Temperature: between -13 and 158 Degrees Fahrenheit
Storage Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Handling Environment Humidity: between 10 and 93 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 50 and 106 KiloPascal
Handling Environment Atmospheric Pressure: between 50 and 106 KiloPascal
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Clinically Relevant Size

[?]
Size Type Text
Length: 17.5 Inch
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Device Record Status

4309e28d-3dca-4aed-82e5-20ed74a03a4f
June 02, 2023
8
May 02, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
Yes
Yes
Yes
No CLOSE

Customer Contact

[?]
480-664-2547
jackie.c@cymedicaortho.com
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