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Accelerated Care Plus Corp.: FDA-registered device maker in Reno, NV, United States, 4 510(k) clearances

Name: Accelerated Care Plus Corp. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Accelerated Care Plus Corp. is registered with the FDA (registration 1911273) in Reno, NV, United States. It lists 9 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 26, 2016. 2 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: 1911273
FEI number: 1000119345
Address: 1170 Trademark Dr Ste 104, Reno, NV, United States, 89521
Owner or operator: Accelerated Care Plus (1911273)
Roles: Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer
First device listed: February 7, 2008
Registered through: 2026
Brand names listed: ACP High Conductivity Electrodes - 2x2, ACP High Conductivity Electrodes - 2x4, ACP High Conductivity Electrodes - 3x5, ACP High Conductivity Electrodes - 4x4, ACPLUS Platform, ACPlus Respiratory Assessment, OmniCycle Connect, OmniCycle Elite 7 Inch Screen and more

Devices it lists

Device	Product code	Class	Role	Source
Device, Biofeedback	HCC	2	Specification developer	accessdata.fda.gov
Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat	IMJ	2	Repackager or relabeler, Specification developer	accessdata.fda.gov
Electrode, Cutaneous	GXY	2	Specification developer	accessdata.fda.gov
Exerciser, Non-Measuring	ION	1	Manufacturer, Specification developer	accessdata.fda.gov
Exerciser, Non-Measuring For Stroke Rehabilitation	PKS	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Exerciser, Powered	BXB	1	Repackager or relabeler, Specification developer	accessdata.fda.gov
Stimulator, Muscle, Powered	IPF	2	Remanufacturer, Repackager or relabeler, Specification developer	accessdata.fda.gov
Stimulator, Nerve, Transcutaneous, For Pain Relief	GZJ	2	Specification developer	accessdata.fda.gov
Stimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat	IMG	2	Specification developer	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
August 26, 2016	K153559	OmniVersa Multi-Modality Therapy System and Omnistim FX2 Professional Therapy System	IMG	Substantially Equivalent	Accelerated Care Plus (Acp)	accessdata.fda.gov
June 14, 2016	K153456	Megapulse III Shortwave Diathermy	IMJ	Substantially Equivalent	Accelerated Care Plus	accessdata.fda.gov
May 23, 2001	K010543	KM-30 TENS ELECTRODE	GXY	Substantially Equivalent	Katecho, Inc.	accessdata.fda.gov
May 2, 1995	K945508	FX-2P NMS (2 CHANNEL PORTABLE)	IPF	Substantially Equivalent	Fx-2	accessdata.fda.gov

Recalls

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

Initiated	Event	Class	Status	Product	Reason	Source
August 25, 2021	88602	Class I	Ongoing	Omnisound Gel, 250 ml bottle and 5 L container; and EcoGel 200, 250 ml bottle; Manufactured by Eco-Med. For use in ultrasound procedures.	Ultrasound gels and lotions manufactured by Eco-Med Pharmaceutical, Inc. may contain bacterial contamination. On August 18, 2021, FDA published a Letter to Health Care Providers to further address this issue: https://www.fda.gov/medical-devices/letters-health-care-providers/stop-using-all-eco-med-ultrasound-gels-and-lotions-due-risk-bacterial-contamination-l	accessdata.fda.gov
June 12, 2013	65498	Class II	Terminated	Omnicycle Elite; US Importer and Distributor: Accelerated Care Plus, Reno NV. Manufactured by Medica Medizintechnik GmbH, Hochdorf, Germany. The product is indicated for powered exercise equipment intended for medical pu	An anomaly in the firmware that may cause Omnicycle Elite to operate at a speed other than what was previously set when in reverse mode.	accessdata.fda.gov

Compare with other makers

Updated August 26, 2016. 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.