The following data is part of a premarket notification filed by The Anspach Effort, Inc. with the FDA for Wireless Hand Control, Eg1a (wireless-hc), Receiver For Wireless Hand Control, Eg1a (receiver-hc).
| Device ID | K220485 |
| 510k Number | K220485 |
| Device Name: | Wireless Hand Control, EG1A (WIRELESS-HC), Receiver For Wireless Hand Control, EG1A (RECEIVER-HC) |
| Classification | Motor, Drill, Electric |
| Applicant | The Anspach Effort, Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 |
| Contact | Marie Ferrier |
| Correspondent | Marie Ferrier Synthes GmbH Eimattstrasse 3 Oberdorf, CH 4436 |
| Product Code | HBC |
| CFR Regulation Number | 882.4360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-02-17 |
| Decision Date | 2022-05-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00845384018766 | K220485 | 000 |
| 00845384018759 | K220485 | 000 |