The following data is part of a premarket notification filed by Regain, Inc. with the FDA for Regain Stand-up Wheelchair.
| Device ID | K946110 |
| 510k Number | K946110 |
| Device Name: | REGAIN STAND-UP WHEELCHAIR |
| Classification | Wheelchair, Standup |
| Applicant | REGAIN, INC. 5577 VANTAGE POINT Columbia, MD 21044 |
| Contact | Michael H Galumbeck |
| Correspondent | Michael H Galumbeck REGAIN, INC. 5577 VANTAGE POINT Columbia, MD 21044 |
| Product Code | IPL |
| CFR Regulation Number | 890.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-14 |
| Decision Date | 1995-02-01 |