AccessGUDID - DEVICE: VECTTOR Therapy System (00869430000215)

GUDID

Device Identifier (DI) Information

Brand Name: VECTTOR Therapy System
Version or Model: VT-200
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: ALAN NEUROMEDICAL TECHNOLOGIES, L.L.C.

Primary DI Number: 00869430000215
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 071665139 *Terms of Use

Device Description: VECTTOR Therapy System Interferential Therapy

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
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:	Yes
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?
36737	Interferential electrical stimulation system	An electrically-powered device assembly designed to stimulate peripheral nerves through the transcutaneous application of two currents of slightly different frequencies (e.g., 4000 and 4100 Hz) that cross-over/interfere, producing a beating frequency (i.e., difference between the frequencies of both stimuli) at the treatment point. It typically consists of an external pulse generator and a set of electrodes placed in position to produce the interference at the desired point. The system is used mainly to relieve/manage intractable pain; some include additional electrodes to provide other types of electrical stimuli or suction for therapeutic massage.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LIH	Interferential Current Therapy

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K121662	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 1438625b-4c86-412f-a60c-7044fb7369c5
Public Version Date: July 06, 2018
Public Version Number: 3
DI Record Publish Date: August 19, 2016