Data / Medical devices / United States / Drive Northpoint, LLC

Drive Northpoint, LLC: FDA-registered device maker in Palmetto, GA, United States, 9 510(k) clearances

Name: Drive Northpoint, LLC FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Drive Northpoint, LLC is registered with the FDA (registration 3044563261) in Palmetto, GA, United States. It lists 26 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 2, 2017. Registered through 2026. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get makers like this one Watch Drive Northpoint, LLC

FDA registration number: 3044563261
Address: 500 Palmetto Logistics Pkwy, Palmetto, GA, United States, 30268
Owner or operator: Medical Depot Inc dba Drive DeVilbiss Healthcare (9040780)
Roles: Manufacturer, Repackager or relabeler
First device listed: May 9, 2001
Registered through: 2026

Devices it lists

Device	Product code	Class	Role	Source
Adaptor, Hygiene	ILS	1	Repackager or relabeler	accessdata.fda.gov
Cable, Electrode	IKD	2	Repackager or relabeler	accessdata.fda.gov
Compressor, Air, Portable	BTI	2	Repackager or relabeler	accessdata.fda.gov
Device, Biofeedback	HCC	2	Manufacturer	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Repackager or relabeler	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Repackager or relabeler	accessdata.fda.gov
Interferential Current Therapy	LIH	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Joint, Ankle, External Brace	ITW	1	Repackager or relabeler	accessdata.fda.gov
Mattress And Bed Deck Cover (Medical Purposes)	QTV	1	Manufacturer	accessdata.fda.gov
Mattress, Air Flotation, Alternating Pressure	FNM	2	Manufacturer	accessdata.fda.gov
Nebulizer (Direct Patient Interface)	CAF	2	Repackager or relabeler	accessdata.fda.gov
Pack, Heat, Moist	IMA	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Repackager or relabeler	accessdata.fda.gov
Pack, Hot Or Cold, Reusable	IME	1	Repackager or relabeler	accessdata.fda.gov
Set, Tubing And Support, Ventilator (W Harness)	BZO	1	Repackager or relabeler	accessdata.fda.gov
Stand, Infusion	FOX	1	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, Over-The-Counter	NUH	2	Manufacturer	accessdata.fda.gov
Stimulator, Neuromuscular, External Functional	GZI	2	Manufacturer	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Manufacturer	accessdata.fda.gov
Tube, Aspirating, Flexible, Connecting	BYY	2	Manufacturer, Repackager or relabeler	accessdata.fda.gov
Tubing, Noninvasive	GAZ	2	Manufacturer	accessdata.fda.gov
Unit, Filter, Membrane	JRL	1	Repackager or relabeler	accessdata.fda.gov
Walker, Mechanical	ITJ	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 2, 2017	K171978	Combo Stimulator MT9000, Combo Stimulator LT7102, TENS Stimulator InTENSity 10	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
November 13, 2015	K150436	ComboRehab	IMG	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
November 22, 2013	K132588	ADHESIVE ELECTRODES	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
September 16, 2013	K130802	OTC ELECTRICAL STIMULATOR (MT9001), OTC TENS DEVICE (LT3060)	NUH	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
February 12, 2010	K093138	MT9000 SERIES ELECTRO-STIMULATOR, MODELS MT9000, MT9002, MT9001, MT9004 AND MT9003	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
January 29, 2010	K100117	LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR	IPF	Substantially Equivalent	Shenzhen Dongdixin Technology Co., Ltd.	accessdata.fda.gov
November 27, 2007	K071624	EVERELIFE TRANSCUTANEOUS MUSCLE STIMULATOR	GZJ	Substantially Equivalent	Everlife Medical Equipment Co., Ltd.	accessdata.fda.gov
May 7, 2007	K070612	TOP-RANK ADHESIVE ELECTRODE	GXY	Substantially Equivalent	Top-Rank Health Care Equipment Co., Ltd.	accessdata.fda.gov
October 7, 2003	K031413	VIGORMIST COMPRESSOR NEBULIZER	BTI	Substantially Equivalent	Vega Technologies, Inc.	accessdata.fda.gov

Compare with other makers

Updated October 2, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.