Data / Medical devices / United States / Infinite Biomedical Technologies, LLC
Infinite Biomedical Technologies, LLC: FDA-registered device maker in Baltimore, MD, United States, 3 510(k) clearances
Infinite Biomedical Technologies, LLC is registered with the FDA (registration 3004426795) in Baltimore, MD, United States. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated April 15, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3004426795
- Address
- 8 Market Place Suite 500, Baltimore, MD, United States, 21202
- Owner or operator
- Infinite Biomedical Technologies (10044353)
- Roles
- Manufacturer
- First device listed
- May 30, 2013
- Registered through
- 2026
- Brand names listed
- Element, FlexCell, FlexCell Mini, Glide, Sense
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrode, Cutaneous | GXY | 2 | Manufacturer | accessdata.fda.gov |
| Hand, External Limb Component, Powered | IQZ | 1 | 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 |
|---|---|---|---|---|---|---|
| April 15, 2024 | K240884 | Glide (91000-GL-X) | GXY | Substantially Equivalent | Infinite Biomedical Technologies, LLC | accessdata.fda.gov |
| October 5, 2018 | K182112 | Sense System with IBT Electrodes | GXY | Substantially Equivalent | Infinite Biomedical Technologies, LLC | accessdata.fda.gov |
| March 21, 2018 | K173571 | Element System with IBT Electrodes | GXY | Substantially Equivalent | Infinite Biomedical Technologies, LLC | accessdata.fda.gov |
Compare with other makers
Updated April 15, 2024. 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.