Data / Medical devices / United States / VQ Orthocare
VQ Orthocare: FDA-registered device maker in Vista, CA, United States, 8 510(k) clearances
VQ Orthocare is registered with the FDA (registration 2031823) in Vista, CA, United States. It lists 10 device types. The FDA files 8 510(k) clearances under its listings, the newest dated November 16, 2020. 1 recall event names it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2031823
- FEI number
- 3002757749
- Address
- 1390 Decision St Ste A, Vista, CA, United States, 92081
- Owner or operator
- VISION QUEST INDUSTRIES, INC. (9022498)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- November 28, 2001
- Registered through
- 2027
- Brand names listed
- ASCENT TLSO, AVID CT2, AVID IF2 Interferential Stimulator, BioniCare Hand, BioniCare Knee, Brace accessories, Catalyst Elite, Catalyst Propel and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cover, Limb | IPM | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Cutaneous | GXY | 2 | Repackager or relabeler | accessdata.fda.gov |
| Interferential Current Therapy | LIH | 2 | Manufacturer | accessdata.fda.gov |
| Orthosis, Cervical-Thoracic, Rigid | IQF | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Limb Brace | IQI | 1 | Manufacturer | accessdata.fda.gov |
| Orthosis, Lumbo-Sacral | IPY | 1 | Specification developer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Repackager or relabeler, Specification developer | accessdata.fda.gov |
| Stimulator, Electrical, Transcutaneous, For Arthritis | NYN | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered | IPF | 2 | Manufacturer | accessdata.fda.gov |
| Support, Arm | IOY | 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 |
|---|---|---|---|---|---|---|
| November 16, 2020 | K202490 | Avid CT2 | IPF | Substantially Equivalent | Vision Quest Industries Inc./Dba VQ Orthocare | accessdata.fda.gov |
| June 12, 2019 | K183692 | Avid IF2 | LIH | Substantially Equivalent | Vision Quest Industries Inc./Dba VQ Orthocare | accessdata.fda.gov |
| April 1, 2016 | K160318 | PlasmaFlow | JOW | Substantially Equivalent | Manamed, Inc. | accessdata.fda.gov |
| June 12, 2014 | K141360 | TRIPLEPLAY PRO | JOW | Substantially Equivalent | Wildcat Medical, Inc. | accessdata.fda.gov |
| January 26, 2011 | K103187 | TRIPLEPLAY-VT VASCULAR THERAPY SYSTEM | JOW | Substantially Equivalent | Wildcat Medical, Inc. | accessdata.fda.gov |
| December 5, 2005 | K052625 | BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | NYN | Substantially Equivalent | Bionicare Medical Technologies, Inc. | accessdata.fda.gov |
| June 6, 2003 | K030332 | MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 | NYN | Substantially Equivalent | Bionicare Medical Technologies, Inc. | accessdata.fda.gov |
| July 5, 2000 | K001117 | COMFORT STIM | GXY | Substantially Equivalent | R & D Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| January 17, 2003 | 26157 | Not yet classified | Terminated | Apex Pilot Shaft, 10mm | Pilot shaft may break during reaming or broaching of the femur | accessdata.fda.gov |
Compare with other makers
- All makers of Interferential Current Therapy
- All makers of Stimulator, Muscle, Powered
- All makers of Sleeve, Limb, Compressible
- All makers of Orthosis, Cervical-Thoracic, Rigid
- All makers of Orthosis, Lumbo-Sacral
- All makers of Stimulator, Electrical, Transcutaneous, For Arthritis
Updated November 16, 2020. 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.