Data / Medical devices / United States / AED Battery Exchange, LLC
AED Battery Exchange, LLC: FDA-registered device maker in Wauconda, IL, United States, 1 510(k) clearance and 1 PMA approval
AED Battery Exchange, LLC is registered with the FDA (registration 3009886119) in Wauconda, IL, United States. It lists 1 device type. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated February 2, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3009886119
- Address
- 1000 Brown St Ste 206, Wauconda, IL, United States, 60084
- Owner or operator
- AED Battery Exchange, LLC (10042298)
- Roles
- Remanufacturer
- First device listed
- November 9, 2012
- Registered through
- 2026
- Brand names listed
- 500-ABE, 5070-ABE, 9141-ABE, 9146-ABE, BT1-ABE, DBP-1400-ABE, DBP-2003-ABE, DCF-200-ABE and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated External Defibrillators (Non-Wearable) | MKJ | 3 | Remanufacturer | 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 1, 2012 | K120350 | EXTENDED LIFE BATTERY | MKJ | Substantially Equivalent | Aed Battery Exchange, LLC | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| February 2, 2021 | P190013 | AED Battery Exchange (Models 9146-ABE, G5-ABE, 5070-ABE, FR3-ABE) | MKJ | 1 | October 28, 2025 | accessdata.fda.gov |
Compare with other makers
Updated October 28, 2025. 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.