The following data is part of a premarket notification filed by James Leckey Design with the FDA for James Leckey Prone Stander.
| Device ID | K944307 |
| 510k Number | K944307 |
| Device Name: | JAMES LECKEY PRONE STANDER |
| Classification | Table, Mechanical |
| Applicant | JAMES LECKEY DESIGN 1250 MAIN ST. Waltham, MA 02154 |
| Contact | James J Falls |
| Correspondent | James J Falls JAMES LECKEY DESIGN 1250 MAIN ST. Waltham, MA 02154 |
| Product Code | INW |
| CFR Regulation Number | 890.3750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-12-22 |