DEVICE: NESS H200® Wireless Hand Rehabilitation System (07290110482060)
Device Identifier (DI) Information
NESS H200® Wireless Hand Rehabilitation System
H2W-5100
In Commercial Distribution
501-00120-01
BIONESS INC.
H2W-5100
In Commercial Distribution
501-00120-01
BIONESS INC.
H200 Wireless US System kit, Right Small
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. |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
IPF | Stimulator, muscle, powered |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
K123636 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
---|
Storage Environment Temperature: between -25 and 70 Degrees Celsius |
Special Storage Condition, Specify: Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
---|
No Device Sizes |
Device Record Status
51f399b6-4a7b-4e01-ad6c-b685bc9b2a41
July 06, 2018
3
February 02, 2017
July 06, 2018
3
February 02, 2017
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+97297907100
100
info@bioness.co.il
info@bioness.co.il