KDY2

Basic Information

• Brand Name: KDY2
• Primary DI: B733KDY20
• Version / Model: SA-201
• Company Name: Sigma Instruments, Inc.
• Labeler DUNS: 049391241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-12-28
• Public Version: 1
• Public Version Date: 2023-01-05
• Public Version Status: New
• Public Device Record Key: 5fc926f1-b924-4f40-aa5e-9faededdcde2

Device Description

Adjusting instrument

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LXM	Manipulator, Plunger-Like Joint	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
58785	Joint/spinal manipulator, electronic	A hand-held, electrically-powered instrument intended to be used by a healthcare professional for the chiropractic adjustment, mobilization, or manipulation of the joints of the spine and/or extremities. The electromechanical instrument is typically pistol-like in shape and uses a plunger-like mechanism to deliver thrust to the patient's body with a single or double rubber-tipped stylus; it typically has several force settings. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B733KDY20	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K962239	000