Data / Medical devices / United States / Renu Medical, Inc.
Renu Medical, Inc.: FDA-registered device maker in Everett, WA, United States, 9 510(k) clearances
Renu Medical, Inc. is registered with the FDA (registration 3034520) in Everett, WA, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated May 7, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034520
- FEI number
- 3003350313
- Address
- 5900 36th Ave W Ste 100, Everett, WA, United States, 98203
- Owner or operator
- RENU MEDICAL, INC. (9046359)
- Roles
- Complaint file establishment, Repackager or relabeler, Reprocessor
- First device listed
- November 17, 2004
- Registered through
- 2026
- Brand names listed
- ALP, Advantage Medical, Aircast Venaflow, Covidein, HoverMatt AirPal, I.V., MULTIPLE MODELS, Many and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cable, Electrode | IKD | 2 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Device, Transfer, Patient, Manual | FMR | 1 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Infusor, Pressure, For I.V. Bags | KZD | 1 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Lift, Patient, Non-Ac-Powered | FSA | 1 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Monitor, Bed Patient | KMI | 1 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Oximeter, Reprocessed | NLF | 2 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 2 | Complaint file establishment, Repackager or relabeler, Reprocessor | accessdata.fda.gov |
| Tourniquet, Pneumatic | KCY | 1 | Complaint file establishment, Repackager or relabeler, Reprocessor | 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 |
|---|---|---|---|---|---|---|
| May 7, 2021 | K203847 | Reprocessed Tri Pulse Compression Garment | JOW | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| June 12, 2012 | K121145 | RENU MEDICAL REPROCESSED AIRCAST VENAFLOW CALF GARMENTS/ALL SIZES, RENU MEDICAL REPROCESSED AIRCAST VENAFLOW THIGH GARME | JOW | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| November 16, 2011 | K111773 | RENU MEDICAL REPROCESSED OXIMAX SENSORS: ADULT, PEDIATRIC, INFANT AND NEONATE | NLF | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| January 14, 2010 | K093658 | RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS | JOW | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| February 6, 2009 | K081927 | RENU MEDICAL OXIMETRY SENSOR, ADULT, PED, INF,NEO | NLF | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| November 29, 2007 | K072194 | RENU REPROCESSED NELLCOR OXIMETRY SENSOR, MODEL D-25, N-25 | NLF | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| May 25, 2007 | K063661 | RENU REPROCESSED NELLCOR OXYSENSOR, MODELS D-20 AND I-20 | NLF | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| April 7, 2006 | K051227 | RENU MEDICAL REPROCESSED ALP 1 CALF GARMENT, MODEL ALP1 | JOW | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
| November 12, 2003 | K031559 | RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES | JOW | Substantially Equivalent | Renu Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Cable, Electrode
- All makers of Sleeve, Limb, Compressible
- All makers of Tourniquet, Pneumatic
- All makers of Oximeter, Reprocessed
- All makers of Lift, Patient, Non-Ac-Powered
- All makers of Device, Transfer, Patient, Manual
Updated May 7, 2021. 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.