The following data is part of a premarket notification filed by Medical Alignment Systems with the FDA for Acculite-ppl 5.
| Device ID | K884787 |
| 510k Number | K884787 |
| Device Name: | ACCULITE-PPL 5 |
| Classification | Sling, Overhead Suspension, Wheelchair |
| Applicant | MEDICAL ALIGNMENT SYSTEMS 9160 SOUTH 300 WEST, BLDG. 1, STE19 Sandy, UT 84070 |
| Contact | Deborah S Stout |
| Correspondent | Deborah S Stout MEDICAL ALIGNMENT SYSTEMS 9160 SOUTH 300 WEST, BLDG. 1, STE19 Sandy, UT 84070 |
| Product Code | INE |
| CFR Regulation Number | 890.3910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-11-15 |
| Decision Date | 1989-01-24 |