Data / Medical devices / United States / Graphic Controls Acquisition Corp.dba Nissha Medical Technologies

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies: FDA-registered device maker in Buffalo, NY, United States, 11 510(k) clearances and 1 PMA approval

Name: Graphic Controls Acquisition Corp.dba Nissha Medical Technologies FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Graphic Controls Acquisition Corp.dba Nissha Medical Technologies is registered with the FDA (registration 1317188) in Buffalo, NY, United States. It lists 14 device types. The FDA files 11 510(k) clearances and 1 PMA approval under its listings, the newest dated June 23, 2023. 6 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 1317188
Address: 400 Exchange St, Buffalo, NY, United States, 14204
Owner or operator: Nissha Medical Technologies (9106359)
Roles: Complaint file establishment, Contract manufacturer, Manufacturer, Manufacturer for export, Repackager or relabeler, Specification developer
First device listed: December 7, 2012
Registered through: 2026
Brand names listed: 1410500 Adult Solid Gel Tape Electrode, BluFlex, ClearScan, EMS Electrodes, Graphic Controls Ultra Film, Guardian, HEART SYNC PEDIATRIC, MODEL PED-100, Heartsync Multifunction Disposable Single-Use AED Defibrillator Pads and more

Devices it lists

Device	Product code	Class	Role	Source
Automated External Defibrillators (Non-Wearable)	MKJ	3	Complaint file establishment, Manufacturer for export, Specification developer	accessdata.fda.gov
Cannula, Sinus	KAM	1	Repackager or relabeler	accessdata.fda.gov
Computer, Diagnostic, Programmable	DQK	2	Contract manufacturer	accessdata.fda.gov
Dc-Defibrillator, Low-Energy, (Including Paddles)	LDD	2	Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Contract manufacturer, Manufacturer	accessdata.fda.gov
Electrode, Electrocardiograph	DRX	2	Contract manufacturer, Manufacturer, Specification developer	accessdata.fda.gov
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	1	Contract manufacturer	accessdata.fda.gov
Piston Syringe Lever	QBL	2	Contract manufacturer	accessdata.fda.gov
Plethysmograph, Impedance	DSB	2	Contract manufacturer	accessdata.fda.gov
Prosthesis, Nose, Internal	FZE	2	Repackager or relabeler	accessdata.fda.gov
Stimulator, Electrical, Evoked Response	GWF	2	Contract manufacturer	accessdata.fda.gov
System, Digital Image Communications, Radiological	LMD	1	Repackager or relabeler	accessdata.fda.gov
Tube, Tympanostomy	ETD	2	Repackager or relabeler	accessdata.fda.gov
Warmer, Infant Radiant	FMT	2	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
September 24, 2008	K081442	HEART SYNC PEDIATRIC, MODEL PED-100	LDD	Substantially Equivalent	Heart Sync, LLC	accessdata.fda.gov
March 3, 2003	K021537	MULTIPURPOSE NEUROPLUS ELECTRODE, MODEL A10005	GXY	Substantially Equivalent	Vermont Medical, Inc.	accessdata.fda.gov
May 3, 2001	K010638	NEUROPLUS, MODEL A10040, A10041, A10042, A10043	GXY	Substantially Equivalent	Vermont Medical, Inc.	accessdata.fda.gov
June 19, 2000	K000801	PC COATED FLUOROPLASTIC VENT TUBES	ETD	Substantially Equivalent	Gyrus Ent LLC	accessdata.fda.gov
August 26, 1999	K992222	FLUOROPLASTIC VENTILATION TUBES	ETD	Substantially Equivalent	Gyrus Ent LLC	accessdata.fda.gov
February 26, 1996	K960477	VENTILATION TUBES	ETD	Substantially Equivalent	Smith & Nephew, Inc.	accessdata.fda.gov
July 26, 1993	K932166	SILICONE TYMPANOSTOMY TUBES	ETD	Substantially Equivalent	Smith & Nephew Richards, Inc.	accessdata.fda.gov
June 8, 1992	K915831	THERMAL PROBE COVER	FMT	Substantially Equivalent	Vermont Medical, Inc.	accessdata.fda.gov
March 2, 1982	K820362	REUTER BOBBIN VENTILA. TUBE-TITANIUM	ETD	Substantially Equivalent	Richard'S Medical Equip., Inc.	accessdata.fda.gov
September 27, 1978	K781574	PLASTI-PORE SEPTAL BUTTON	FZE	Substantially Equivalent	Richard'S Medical Equip., Inc.	accessdata.fda.gov
September 21, 1976	K760438	SPOON-BOBBIN DRAIN TUBE W/ WIRE, OTOLOGY	ETD	Substantially Equivalent	Richard'S Medical Equip., Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 23, 2023	P200007	HeartSync Multifunction Disposable Single-Use AED Defibrillator Pads	MKJ	2	December 19, 2025	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
March 15, 2022	89810	Class II	Terminated	CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US	Instructions for Use (IFU) (Instructions for Use) indicate compliance with ANSI/AAMI EC53:2013/(R)2020 ECG trunk cables and patient leadwires. Section 5.3.9 of the standard requires the device to withstand, without breakdown, an application of, 5,000 V d.c. when used with a defibrillator at a voltage above its maximum threshold, Claravue does not meet the sp	accessdata.fda.gov
November 11, 2014	69875	Class I	Terminated	ADULT Radiotransparent Electrode, Part number C100-PHILIPS, Rx ONLY, For use with Philips HeartStart AED "Comparable to Philips Medical HeartStart Electrodes Plug Style Connector", Intended for use during defibrillation,	Heart Sync Multi-function defibrillation electrodes will not connect with Philips FR3 or FRx AED units. The FRx AED unit requires the pads to be pre-connected, and will issue a continuous alarm chirp to alert the user that the proper pads are not connected to the unit prior to use. The FR3, however, does not require pre-connection and the user may not discov	accessdata.fda.gov
April 26, 2013	65085	Class II	Terminated	Heart Sync C100-Physio Radiotransparent Defibrillation Electrodes Monophasic or biphasic compatible pacing/ cardioversion Defibrillation /ECG Monitoring electrodes Used in connection with a defibrillator to deliver an el	On 4/18/13 HEARTSYNC became aware of a recall from their wire/connector sub-assembly supplier which is used in the C100-Physio Electrodes. There were reports of equipment damage due to misalignment from tooling installed in August 2012. The result of this damage could render the device incapable of delivering the appropriate energy or shock to the patient.	accessdata.fda.gov
February 8, 2011	58052	Not yet classified	Terminated	HealthPort BioAnologics Patient Electrode Sensor Test Kit, Part # SEN-0025-0, 25 kits/carton Each kit contains 100 tab electrodes and 26 alcohol pads. The electrodes are used to measure bodyfat analysis. The alcohol pads	Vermed kits contain a product component (Triad Alcohol Prep Pads) recalled due to potential Bacillus cereus contamination.	accessdata.fda.gov
December 17, 2010	57736	Not yet classified	Terminated	Medstorm Adult Radiolucent Electrode Philips Medical, Part #16250, HeartSync Ann Arbor, MI. The Adult Radiolucent Multifunction Tin Electrodes are indicated for use in external pacing, defibrillation and monitoring appli	The seal on the electrode pouch may be open, exposing the electrode to the outside environment. The package does have a caution statement that states, " Do not open package until immediately prior to using electrodes. and Electrodes may dry out when removed from packaging and exposed to air.	accessdata.fda.gov
December 5, 2008	57815	Not yet classified	Terminated	Medstorm Adult Radiolucent Leads-Out Electrode - Physio-Control, Part 16242. Indicated for use in external pacing, defibrillation and monitoring applications as a non-sterile, disposable device for single patient use onl	The "leads out" connector had bent pins which would not allow connection to the Medtronic Physio Control Defibrillator cable during a product demonstration.	accessdata.fda.gov

Compare with other makers

Updated December 19, 2025. 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.