510(k) K220485
K220485 is an FDA 510(k) premarket notification submitted by The Anspach Effort, Inc. for the device "Wireless Hand Control, EG1A (WIRELESS-HC), Receiver for Wireless Hand Control, EG1A (RECEIVER-HC)". The FDA issued a decision of Substantially Equivalent on May 19, 2022. The device falls under product code HBC (Motor, Drill, Electric), a Class II device regulated under 21 CFR 882.4360. The Anspach Effort, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 19, 2022
- Date Received
- February 17, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Electric
- Device Class
- Class II
- Regulation Number
- 882.4360
- Review Panel
- NE
- Submission Type