Question 1

What type of medical device does Allotrope Medical, Inc. manufacture?

Accepted Answer

Allotrope Medical, Inc. focuses on nerve‑locating systems, which are devices used to identify peripheral nerves during surgery. This conclusion comes directly from the device category listed as “Nerve‑locating system” and the summary describing their products as tools for precise nerve localization.

Question 2

Where is Allotrope Medical, Inc. headquartered?

Accepted Answer

The company is based in the United States, as indicated by the COUNTRY field stating “US.” This location is also consistent with the regulatory listings that reference FDA databases, which apply to U.S. manufacturers.

Question 3

In which FDA registries are Allotrope Medical’s devices listed?

Accepted Answer

Allotrope Medical’s devices appear in the FDA’s 510(k) database and the Unique Device Identifier (UDI) database. The LISTED IN field explicitly names “fda_510k” and “fda_udi,” confirming that their nerve‑locating systems are recorded in both of these FDA registries.

Question 4

How are Allotrope Medical’s nerve‑locating systems classified under FDA regulations?

Accepted Answer

The devices are classified as Class II under FDA regulations. This classification is stated in the DEVICE CLASSES entry, indicating that the nerve‑locating systems are considered moderate‑risk devices requiring special controls.

Device	Model / Reference	Registries	Class	Status
StimSite	AM 100	FDA UDI	Class II	Active
StimSite	AM-BP1	FDA UDI	Class II	Active
StimSite	AM-DA1	FDA UDI	Class II	Active
StimSite	AM-LS1	FDA UDI	Class II	Active
StimSite	K200886	FDA 510(k)FDA UDI	Class II	Active

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