DEVICE: WELLNESSPRO (B243SSWP2010PLUS0)

Device Identifier (DI) Information

WELLNESSPRO
2010 PLUS
In Commercial Distribution

ELECTRO MEDICAL TECHNOLOGIES, LLC
B243SSWP2010PLUS0
HIBCC

1
160641309 *Terms of Use
Transcutaneous Electrical Nerve Stimulator for Pain. The WellnessPro 2010 Plus is designed to provide electrical stimulation, for relief of chronic, intractable pain and as an adjunctive treatment of post-surgical or port-traumatic acute pain, in a single compact, lightweight user friendly package.
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Device Characteristics

Labeling does not contain MRI Safety Information
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GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Analgesic TENS system An assembly of battery-powered devices used to reduce the perception of pain by electrically stimulating peripheral nerves across the skin (transcutaneously). It typically consists of external current generator and electrodes that are placed on the skin to provide the transcutaneous analgesic electrical stimulus to the painful area. 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, 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
GZJ Stimulator, Nerve, Transcutaneous, For Pain Relief
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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

2b407420-2105-43f5-807a-6d03a6f10a2d
March 29, 2018
2
July 21, 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)

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No
No
None
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Production Identifier(s) in UDI

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No
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No
Yes
No CLOSE

Customer Contact

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1-888-880-7888
info@electromedtech.com
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