DEVICE: Sharper Image (00856759006844)

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Device Identifier (DI) Information
Sharper Image
205073-01

Camelot Si, LLC
00856759006844
GS1
1
TENS Massager with Remote Control
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
Yes
Yes
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
Transcutaneous electrical stimulation electrode A non-sterile electrical conductor intended to be attached to a patient's skin (noninvasive) to provide therapeutic electrical stimuli through the body surface [e.g., transcutaneous electrical nerve stimulation (TENS), electrical muscle stimulation, cranial electrotherapy stimulation (CES)]. It is typically a flat, flexible, conductive pad with an adhesive (e.g., gel), or a preformed shape/mechanism designed for attachment to a particular body part (e.g., earclip), connected to a conductive wire. This is a single-patient device that may be reapplied to the patient over a short term (single-use) before being discarded.
Transcutaneous electrical stimulation lead A non-sterile, insulated, electrical conducting wire intended to be used to connect a transcutaneous electrical stimulation electrode to an electrical stimulus generator (e.g., TENS system generator), or a wire having a distal end that splits and terminates as electrodes which are placed on the patient for the transmission of electrical stimulation. This is a reusable device.
Physical therapy electrical stimulation system, battery-powered An assembly of battery-powered devices used to apply various modes of electrical stimulation transcutaneously to treat/prevent neuromuscular symptoms and disorders typically as a form of physical therapy. It typically includes an electric current pulse generator, electrodes/probes, audible and/or visual indicators, and software. It may provide biofeedback and/or transcutaneous electrical nerve stimulation (TENS) to treat pain. It is typically used to prevent muscle atrophy, for muscle re-education, to relax muscle spasms, to improve blood circulation, for postsurgical stimulation of calf muscles to prevent venous thrombosis, and/or to maintain or increase range of motion.
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FDA Product Code

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Product Code Product Code Name
No Product Codes
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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 Status
In Commercial Distribution
February 01, 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
00854761007071 20 00856759006844 In Commercial Distribution
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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
No
No
Yes
No CLOSE

Customer Contact

[?]
1 877 210 3449
productideas@sharperimageonline.com
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