AccessGUDID - DEVICE: Khan Kinetic Treatment Device (KKT-M2) (B854M20)

GUDID

Device Identifier (DI) Information

Brand Name: Khan Kinetic Treatment Device (KKT-M2)
Version or Model: KKT-M2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: M2
Company Name: Optima Health Solutions International Corporation

Primary DI Number: B854M20
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 204132596 *Terms of Use

Device Description: The KKT-M2 device is to be used in the aid of management of chronic pain due to non-congenital defects. The device can be used as part of a series of steps in the total care of the patient. The procedure involves the use of diagnostic imaging that qualifies the misalignment between vertebrae. The treatment is then administered using the KKT-M2 device to deliver precise impulses at a required vector configuration.

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:	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?
11248	Physical therapy ultrasound system	An assembly of devices designed to produce and deliver ultrasonic waves that penetrate tissues and produce both thermal and nonthermal (e.g., mechanical and cavitation) effects to treat pain (e.g., muscle, tendon, joint) and as an aid in the healing of soft-tissue injuries (e.g., ulcerations, bursitis). It typically consists of a radio-frequency (RF) generator (frequencies from one to three megahertz are typical), a cable that transmits the RF energy to the applicator, and an applicator including a piezoelectric transducer that applies the ultrasonic energy to the patient's tissues through the skin.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LXM	Manipulator, Plunger-Like Joint

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K130666	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: bd4dbbfa-4ad2-4e55-9f22-0e35c6846e4c
Public Version Date: April 01, 2022
Public Version Number: 1
DI Record Publish Date: March 24, 2022