K864152 is an FDA 510(k) clearance for the BACK SAVER LIFT BELT/WHEELCHAIR TRANSFER DEVICE. This device is classified as a Transport, Patient, Powered (Class II - Special Controls, product code ILK).
Submitted by Lossing Orthopedic, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 5, 1987, 105 days after receiving the submission on October 23, 1986.
This device falls under the Physical Medicine FDA review panel. Regulated under 21 CFR 890.5150. A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs..
| 510(k) Number | K864152 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 23, 1986 |
| Decision Date | February 05, 1987 |
| Days to Decision | 105 days |
| Submission Type | Traditional |
| Review Panel | Physical Medicine (PM) |
| Summary | — |
| Product Code | ILK — Transport, Patient, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 890.5150 |
| Definition | A Powered Patient Transport Is A Motorized Device Intended For Use In Mitigating Mobility Impairment Caused By Injury Or Other Disease By Moving A Person From One Location Or Level To Another, Such As Up And Down Flights Of Stairs (e.g., Attendant-operated Portable Stair-climbing Chairs). This Generic Type Of Device Does Not Include Motorized Three-wheeled Vehicles Or Wheelchairs. |