The following data is part of a premarket notification filed by D.t. Davis Enterprises Ltd. T/a Hovertech Int'l with the FDA for Ht-wedge.
| Device ID | K121287 |
| 510k Number | K121287 |
| Device Name: | HT-WEDGE |
| Classification | Lift, Patient, Ac-powered |
| Applicant | D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem, PA 18015 |
| Contact | Susan Pavelko |
| Correspondent | Susan Pavelko D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L 513 SOUTH CLEWELL STREET Bethlehem, PA 18015 |
| Product Code | FNG |
| CFR Regulation Number | 880.5500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-30 |
| Decision Date | 2012-10-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00816299011388 | K121287 | 000 |