Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)
Summary
The Anspach Effort, Inc. received 510(k) clearance for Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC), a HBC device. Cleared on 2022-05-19.
Details
Source
510(k) Clearance
External ID
K220485
Action Date
2022-05-19
Status
Traditional
Category
device
Product Code
HBC
Product Description
Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC). Product code: HBC.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
The Anspach Effort, Inc. has 10 FDA actions in our database, including 9 recalls and 1 clearance.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does The Anspach Effort, Inc. have FDA actions?
The Anspach Effort, Inc. has 10 FDA actions in our database, including 9 recalls and 1 device clearance.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K220485" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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