Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

2027046

FEI Number

2027046

Entity Name

ACI MEDICAL, LLC

City/State/Country

SAN MARCOS, CA, US

Establishment Address

1857 DIAMOND ST, SAN MARCOS, CA 92078, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

ACI MEDICAL, LLC (Owner Number: 2027046)

Owner / Operator Contact Address

1857 DIAMOND ST, --, San Marcos, CA 92078, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

APG Air-Plethysmograph VenAssist ArtAssist FlowDyn MagicWear Wrap

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2007-12-28
JOW	Sleeve, Limb, Compressible	Cardiovascular	Class 2	870.5800	2007-12-28
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2017-06-02
MDR	Binder, Medical, Therapeutic	General Hospital	Class 1	880.5160	2025-05-28

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

ACI MEDICAL, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K170216	Tactile Systems Technology, Inc. (Dba Tactile Medical)	Flexitouch System	2017-05-26
K100306	Covidien	KENDALL SCD SEQUENTIAL COMPRESSION COMFORT SLEEVES	2010-05-04

Similar Registrations

Registration Number	Establishment Name	Location
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3009156722	SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD.	Shenzhen Guangdong, CN
3004782476	Impedimed Limited	Lindfield New South Wales, AU
3007305624	GUANGDONG BIOLIGHT MEDITECH CO., LTD	Zhuhai Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2027046. Last updated year: 2026. Please use registration number 2027046 when referencing this establishment in official correspondence.