Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, …

FDA 510(k)

Class II (US FDA 510(k))

510(k) K220485

Identifiers

510(k) Number: K220485 FDA 510(k)
FDA Product Code: HBC FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 882.4360 FDA 510(k)
Regulation Number: 882.4360 FDA 510(k)
Advisory Committee: Neurology FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, … by The Anspach Effort, Inc. — Class II — FDA_510K — listed in FDA 510(k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K220485	Class II	Active

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Manufacturer

Manufacturer: The Anspach Effort, Inc.

Sources (1)

FDA 510(k) K220485 24 fields · synced Jun 18, 2026