HT-WEDGE
FDA 510(k) clearance K121287 · decided 2012-10-03
Clearance details
- K-number
- K121287
- Device name
- HT-WEDGE
- Applicant
- D.T. Davis Enterprises Ltd. T/A Hovertech Int'L
- Decision
- Substantially Equivalent
- Date received
- 2012-04-30
- Decision date
- 2012-10-03
- Days to decision
- 156 days
- Clearance type
- Traditional
- Product code
- FNG
- Device class
- 2
- Regulation number
- 880.5500
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Bethlehem, PA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HOVERJACK AIR PATIENT LIFT DEVICE (K041503) | D.T. Davis Enterprises , Ltd. | 2004-08-12 |
| PATIENT SUPPORT SYSTEM (K940872) | Arylift, Inc. | 1994-10-13 |
| A.C. POWER PATIENT LIFT (K935351) | Ken Kemmerer | 1994-02-28 |
| SAF-LIFT/SAF-KARY (K926411) | Arjo-Century, Inc. | 1993-03-31 |
| PATIENT LIFT AND TRANSPORT (K912769) | Century Manufacturing Co. | 1991-10-02 |
| MANGAR BOOSTER (K905414) | Northfleet Management Group, Inc. | 1991-03-05 |
| THE MURRAY MOBILIFT(TM) (K895677) | Medical/Surgical Specialties, Ltd. | 1990-10-26 |
| BARRIER FREE CEILING LIFT, MDLS HRS-1/2F,1/4F,1/6F (K903723) | Barrier Free Lifts, Inc. | 1990-09-24 |
| LIFT MASTER PATIENT LIFT (K896848) | Henry Enterprises, Inc. | 1990-05-29 |
| PERSONAL TRANSFER SYSTEM (K885270) | Columbus Mckinnon Corp. | 1989-03-14 |
| BOMDAL STANDARD LIFT (K862147) | Bomdal Medical Equipment, Inc. | 1986-07-15 |
| BOMDAL TRAVELMASTER LIFT (K862146) | Bomdal Medical Equipment, Inc. | 1986-07-15 |
Recalls involving this device
No recalls on record reference this clearance.