DEVICE: ProActive Alevia 2 in 1 TENS (00775757154251)

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Device Record History
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Device Identifier (DI) Information
ProActive Alevia 2 in 1 TENS
715-425
In Commercial Distribution
715-425
A.M.G. Médicale Inc
00775757154251
GS1

1
207372814 *Terms of Use
The TENS 2-in-1 Physiotherapy Alevia™ by ProActive™ is a 2-in-1 (TENS and EMS) device that gives you the ability to fully customize treatment options or choose one of the 18 pre-set programs. It has a large, easy-to-read LCD and includes all accessories. The Alevia™ comes complete with 4 self-adhesive, pre-gelled and reusable electrodes, one rechargeable battery with USB Cable, lead wires, instructions and a storage bag. ProActive™ offers a complete line of physiotherapy devices, clinically proven to relieve pain without drugs, including a full line-up of electrodes. The Alevia™ Dual channel TENS Electro-Stimulator relieves pain in 2 ways: TENS (Transcutaneous Nerve Stimulation) stimulates or numbs nerves EMS (Electrical Muscle Stimulation) prevents atrophy
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Device Characteristics
Labeling does not contain MRI Safety Information
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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?
35372 Analgesic transcutaneous electrical nerve stimulation system
An assembly of electrically-powered devices designed to reduce the perception of pain by electrically stimulating peripheral nerves across the skin [transcutaneous electrical nerve stimulation (TENS)]. It includes an external current generator and skin-surface electrodes. It typically includes several predetermined stimulation options and is often worn on a belt or carried in a pocket of the user. It is intended for use in the home and healthcare facility to treat pain from surgery, trauma, musculoskeletal problems/arthritis, bursitis, dental problems, and may be used in physical therapy and during labour/delivery.
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FDA Product Code

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Product Code Product Code Name
NGX Stimulator, Muscle, Powered, For Muscle Conditioning
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization
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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
6895a91f-5d72-47e6-a22e-9a1d7587ff00
June 20, 2023
1
June 12, 2023
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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
00057565994664 6 00775757154251 In Commercial Distribution Master Case
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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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None
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Production Identifier(s) in UDI

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Customer Contact

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No Customer Contact currently defined
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