DEVICE: PURE ENRICHMENT (B311PETNEMHT0)

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Device Record History
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Device Identifier (DI) Information
PURE ENRICHMENT
PETNEMHT
In Commercial Distribution

BEAR DOWN CONSULTING
B311PETNEMHT0
HIBCC

1
040869867 *Terms of Use
No description.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
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GMDN

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GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. 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

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Product Code Product Code Name
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K221384 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
2ab9d5d9-0f24-47a3-8cfd-11cfa5e34a07
June 02, 2023
2
August 12, 2022
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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
B311PETNEMHT1 32 B311PETNEMHT0 In Commercial Distribution MASTER CARTON
B311PETNEMHT2 4 B311PETNEMHT0 In Commercial Distribution INNER CARTON
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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)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
Yes
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Customer Contact

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No Customer Contact currently defined
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