AccessGUDID - DEVICE: NESS H200® Wireless Hand Rehabilitation System (07290110482060)

GUDID

Device Identifier (DI) Information

Brand Name: NESS H200® Wireless Hand Rehabilitation System
Version or Model: H2W-5100
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 501-00120-01
Company Name: BIONESS INC.

Primary DI Number: 07290110482060
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 182287727 *Terms of Use

Device Description: H200 Wireless US System kit, Right Small

Device Characteristics

What MRI safety information does the labeling contain?	MR Unsafe
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	Yes
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	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
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.

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

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

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

Public Device Record Key: 51f399b6-4a7b-4e01-ad6c-b685bc9b2a41
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: February 02, 2017