FDA Registration
Active
🇺🇸 United States
ACI MEDICAL, LLC
Reg #: 2027046
·
FEI: 2027046
·
Expires 2026
Products
5
Proprietary Names
8
Establishment Types
1
Classifications
5
Registration Details
- Registration Name
- ACI MEDICAL, LLC
- Registration Number
- 2027046
- FEI Number
- 2027046
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1857 DIAMOND ST
- City
- SAN MARCOS
- State
- CA
- ZIP
- 92078
- Country
- US
Regulatory Submissions
- 510(k) Number
- K881291
Owner / Operator
- Firm Name
- ACI MEDICAL, LLC
- Operator Number
- 2027046
- Address
- 1857 DIAMOND ST, --
- City
- San Marcos
- State
- CA
- Postal Code
- 92078
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2007-12-28 |
| Sleeve, Limb, Compressible | JOW | Class 2 | Cardiovascular | No | 2007-12-28 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2017-06-02 |
| Binder, Medical, Therapeutic | MDR | Class 1 | General Hospital | No | 2025-05-28 |
| Legging, Compression, Non-Inflatable | LLK | Class 2 | General Hospital | No | 2016-12-16 |
Proprietary Names
APG Air-Plethysmograph
VenAssist
ArtAssist
FlowDyn
MagicWear Wrap
VenaPulse
UnnaSleeve
ArtAssist Device
Establishment Types
Manufacture Medical Device