DEVICE: Pointer Excel II (14897076720054)
Device Identifier (DI) Information
Pointer Excel II
ED3988
In Commercial Distribution
ED3988
TENS PLUS INDUSTRIAL COMPANY
ED3988
In Commercial Distribution
ED3988
TENS PLUS INDUSTRIAL COMPANY
Pointer Excel II is the latest and most advanced user friendly stimulator. Features a built-in, 0.35" x 1.0" LCD digital meter which displays both frequency and location. Unit features two grounding plates on the unit (allowing use with either left or right hands) as well as a hand probe with grounding pole and attached wire. Two probe tips are included with unit: ear 2 mm (0.08") and body 4 mm (0.16"). Other standard accessories include 9 volt battery, carrying case, and instructions.
Device Characteristics
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GMDN
[?]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? |
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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
[?]Product Code | Product Code Name |
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GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K060517 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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No storage/handling found |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
029d0ad0-aff2-46df-94db-78d4622119f6
October 23, 2019
4
August 04, 2016
October 23, 2019
4
August 04, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
---|---|---|---|---|---|
34897076720058 | 30 | 14897076720054 | In Commercial Distribution | Master Case |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
800-722-8775
customerservice@lhasaoms.com
customerservice@lhasaoms.com