DEVICE: SPT (00876840016231)

Device Identifier (DI) Information

SPT
UC-031
In Commercial Distribution

SUNPENTOWN INTERNATIONAL, INC.
00876840016231
GS1

1
848632097 *Terms of Use
Delivers electric impulses to tired and sore muscles. The muscles respond to the impulses by contracting and relaxing rhythmically, which sends soothing massage sensations to relieve muscle tension and soreness. Six massage modes with 10 intensity levels each provide various combinations of massage sensaations. The body tends to get accustomed to one particular sensation and will eventually stop responding to it, the different sensations available on this unit ensures that the body does not become desensitized.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
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Yes
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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.
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
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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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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

19eabbb2-cc55-4d27-9f1f-002224e541b7
October 23, 2019
3
February 17, 2017
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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
10876840016238 12 00876840016231 In Commercial Distribution 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
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Yes
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Customer Contact

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No Customer Contact currently defined
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