Data / Medical devices / United States / A-1 Engineering
A-1 Engineering: FDA-registered device maker in Irvine, CA, United States, 2 510(k) clearances
A-1 Engineering is registered with the FDA (registration 3007008050) in Irvine, CA, United States. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated September 3, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3007008050
- FEI number
- 3008069988
- Address
- 30 Mauchly Ste A, Irvine, CA, United States, 92618
- Owner or operator
- A-1 Engineering (10026191)
- Roles
- Manufacturer
- First device listed
- June 18, 2008
- Registered through
- 2026
- Brand names listed
- NeurotriS, NeurotriS SVX 650, NeurotriS SX 101, NeurotriS SX 2500, NeurotriS SX 3300, NeurotriS SX 3800, NeurotriS SX 4500, NeurotriS SX 50 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 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 |
|---|---|---|---|---|---|---|
| September 3, 2025 | K251909 | NeurotriS (SX2500); NeurotriS (SX3800) | NFO | Substantially Equivalent | A-1 Engineering | accessdata.fda.gov |
| February 26, 2019 | K182440 | Body System | NGX | Substantially Equivalent | A-1 Engineering | accessdata.fda.gov |
Compare with other makers
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Massager, Therapeutic, Electric
Updated September 3, 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.