DEVICE: NESS H200® Wireless Hand Rehabilitation System (07290110482015)

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Device Identifier (DI) Information

NESS H200® Wireless Hand Rehabilitation System
H2W-5200
501-00038-01
BIONESS INC.
07290110482015
GS1
1
H200 Wireless US System kit, Left Medium
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Device Characteristics

MR Unsafe
No
No
No
Yes
No
Yes
No
No

GMDN

[?]

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

GMDN Preferred Term Name GMDN Definition
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

[?]
Product Code Product Code Name
IPF Stimulator, muscle, powered
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Storage Environment Temperature: between -25 and 70 Degrees Celsius
Special Storage Condition, Specify: Degrees Celsius
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
February 02, 2017

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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
+97297907100 100
info@bioness.co.il
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