AccessGUDID - DEVICE: WalkLink Unit (00858184006055)

GUDID

Device Identifier (DI) Information

Brand Name: WalkLink Unit
Version or Model: 20-0310
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: INNOVATIVE NEUROTRONICS, INC.

Primary DI Number: 00858184006055
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 791468734 *Terms of Use

Device Description: Provides a wireless connection between the WalkAide and a computer, and also allows manual stimulation during walking trials via the Hand Switch.

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:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
35725	Gait-enhancement electrical stimulation system, external	An assembly of devices that applies electrical stimuli to the lower extremity nerves (e.g., peroneal or femoral) or muscles (e.g., those that cause ankle dorsiflexion), to cause the muscles in the leg to contract, thus improving the gait in a patient suffering from partial paralysis of the lower extremities or other neuromuscular disorders. It typically includes electrodes and an external pulse generator (EPG), and may be incorporated into an external prosthesis.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
GZI	Stimulator, Neuromuscular, External Functional

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K140886	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 Humidity: between 0 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -4 and 158 Degrees Fahrenheit
Handling Environment Humidity: between 0 and 95 Percent (%) Relative Humidity
Handling Environment Temperature: between -4 and 158 Degrees Fahrenheit

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: edf57b08-9f27-4463-8c03-3eb6d518480e
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 16, 2016