The following data is part of a premarket notification filed by Modern Rehabilitation Solutions Co., Ltd with the FDA for 18 Standard Wheelchair, Model Ms005-4, 18 Reclining Wheelchair , Model Ms008-1, 14 Pediatric Wheelchair.
| Device ID | K094047 |
| 510k Number | K094047 |
| Device Name: | 18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR |
| Classification | Wheelchair, Mechanical |
| Applicant | MODERN REHABILITATION SOLUTIONS CO., LTD 5401 S COTTONWOOD CT Greenwood Village, CO 80121 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls MODERN REHABILITATION SOLUTIONS CO., LTD 5401 S COTTONWOOD CT Greenwood Village, CO 80121 |
| Product Code | IOR |
| CFR Regulation Number | 890.3850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-03-22 |