SetPoint Charger and Docking Station

Primary DI: 00860013950217
Brand: SetPoint Charger and Docking Station
Company: SetPoint Medical Corporation
Model: K01
Published: 2025-08-12
Public version status: Update
Distribution status: In Commercial Distribution
MRI safety: Labeling does not contain MRI Safety Information
Rx: true

Product Codes#

Code, Name table
Code	Name
SFJ	Vagus Nerve Stimulator For Rheumatoid Arthritis

Product Code Classifications#

Code, Device, Specialty table
Code	Device	Specialty	Class
SFJ	Vagus Nerve Stimulator For Rheumatoid Arthritis	Unknown	3

Premarket Submissions#

Submission, Supplement table
Submission	Supplement
P240039	000

Premarket Details#

Submission, Supplement, Device table
Submission	Supplement	Device	Applicant	Decision date	Product code
P240039	000	SetPoint System	SetPoint Medical	2025-07-30	SFJ

Identifiers And Packaging#

Identifier, Type, Agency table
Identifier	Type	Agency	Package quantity	Status
00860013950217	Primary	GS1	0

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifier	GTIN-14 normalized	UPC-A	EAN-13
00860013950217	00860013950217	860013950217	0860013950217

GMDN Terms#

Term, Definition table
Term	Definition
Antiseizure/psychiatric-therapy vagus nerve implantable electrical stimulation system	An assembly of battery-powered devices intended to apply periodic electrical stimuli to the vagus nerve to help control seizures and/or to help treat psychiatric disorder symptoms (e.g., depression). The vagus nerve stimulation (VNS) is provided through an implantable pulse generator, typically placed in the anterior chest wall, and leads that run subcutaneously to where their electrodes are implanted around the left vagus nerve. The system may be programmed externally following implantation.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number: 957136315
Device count: 1
Kit: true
Serial number: true
Manufacturing date on label: true
Expiration date on label: true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DI	Brand	Model	Catalog	Published
00860013950224	SetPoint Charger	E04		2025-08-12
00860013950231	SetPoint Docking Station	C01		2025-08-12
00860013950248	SetPoint Programmer	v2		2025-08-12
00860013950200	SetPoint Implant	M01		2025-08-06

Primary DI, Brand, Company table
Primary DI	Brand	Company	Product code	Published
00860013950224	SetPoint Charger	SetPoint Medical Corporation	SFJ	2025-08-12
00860013950231	SetPoint Docking Station	SetPoint Medical Corporation	SFJ	2025-08-12
00860013950248	SetPoint Programmer	SetPoint Medical Corporation	SFJ	2025-08-12
00860013950200	SetPoint Implant	SetPoint Medical Corporation	SFJ	2025-08-06