Data / Medical devices / United States / Aci Medical, LLC
Aci Medical, LLC: FDA-registered device maker in San Marcos, CA, United States, 5 510(k) clearances
Aci Medical, LLC is registered with the FDA (registration 2027046) in San Marcos, CA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated February 10, 2014. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2027046
- Address
- 1857 Diamond ST, San Marcos, CA, United States, 92078
- Owner or operator
- ACI MEDICAL, LLC (2027046)
- Roles
- Manufacturer
- First device listed
- December 28, 2007
- Registered through
- 2026
- Brand names listed
- APG Air-Plethysmograph, ArtAssist, ArtAssist Device, FlowDyn, MagicWear Wrap, UnnaSleeve, VenAssist, VenaPulse
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Binder, Medical, Therapeutic | MDR | 1 | Manufacturer | accessdata.fda.gov |
| Legging, Compression, Non-Inflatable | LLK | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Plethysmograph, Impedance | DSB | 2 | Manufacturer | accessdata.fda.gov |
| Sleeve, Limb, Compressible | JOW | 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 |
|---|---|---|---|---|---|---|
| February 10, 2014 | K131146 | ARTASSIST AND VENASSIST | JOW | Substantially Equivalent | Aci Medical, LLC | accessdata.fda.gov |
| February 28, 1996 | K942530 | ART-ASSIST MODEL AA-1000 | JOW | Substantially Equivalent | Aci Medical, Inc. | accessdata.fda.gov |
| April 3, 1991 | K903894 | VENAPULSE MODELS VP-25 AND VP-50 | JOW | Substantially Equivalent | Aci Medical, Inc. | accessdata.fda.gov |
| November 2, 1990 | K903532 | UNNA-SLEEVE(TM) | LLK | Substantially Equivalent | Aci Medical, Inc. | accessdata.fda.gov |
| October 14, 1988 | K881291 | AIR PLETHYSMOGRAPH MODEL APG-1000 | DSB | Substantially Equivalent | Aci Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Sleeve, Limb, Compressible
- All makers of Plethysmograph, Impedance
- All makers of Massager, Therapeutic, Electric
- All makers of Legging, Compression, Non-Inflatable
- All makers of Binder, Medical, Therapeutic
Updated February 10, 2014. 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.