DEVICE: Omron Max Power Relief (00073796303235)

Device Identifier (DI) Information

Omron Max Power Relief
PM3032CAN
In Commercial Distribution
PM3032CAN
Omron Healthcare, Inc.
00073796303235
GS1

1
054318779 *Terms of Use
Electrotherapy Pain Relief TENS Unit
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
Yes
No
No
No

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
NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K141978 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

ae5c2dca-15ed-461e-86de-662681107fb9
July 06, 2018
3
May 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
10073796303232 6 00073796303235 In Commercial Distribution 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)

[?]
No
No
None
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Production Identifier(s) in UDI

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Yes
Yes
Yes
No
No CLOSE

Customer Contact

[?]
1-800-634-4350
quality@omron.com
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