Accelerated Care Plus Corp.
Reno, NV, US
ACCELERATED CARE PLUS CORP. appears in FDA device records in Reno, NV. FDA records list 3 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 3 510(k) clearances for Accelerated Care Plus Corp. between 2006 and 2016. The busiest year on record is 2006, with 1. The most recent is 2016, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2006 | 1 |
| 2009 | 1 |
| 2016 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K153456 | Megapulse III Shortwave Diathermy | IMJ | Substantially Equivalent | |
| K093600 | OMNISTIM CONTINENCE+ PELVIC FLOOR STIMULATION SYSTEM | KPI | Substantially Equivalent | |
| K060191 | ACP OMNIPAD LIGHT THERAPY SYSTEM & ACP OMNIPAD 500 CONTROL UNIT | ILY | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1911273 | 1000119345 | ACCELERATED CARE PLUS CORP. | 1170 Trademark Dr Ste 104, RENO, NV 89521 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- HCCDevice, Biofeedback
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- GXYElectrode, Cutaneous
- IONExerciser, Non-Measuring
- PKSExerciser, Non-Measuring For Stroke Rehabilitation
- BXBExerciser, Powered
- ILYLamp, Infrared, Therapeutic Heating
- KPIStimulator, Electrical, Non-Implantable, For Incontinence
- IPFStimulator, Muscle, Powered
- GZJStimulator, Nerve, Transcutaneous, For Pain Relief
- IMGStimulator, Ultrasound And Muscle, For Use In Applying Therapeutic Deep Heat
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-2518-2021 | 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-letter-health | Class I | Open, Classified | |
| Z-1837-2013 | 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 purposes. | 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. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain