The following data is part of a premarket notification filed by Dynamic Systems, Inc. with the FDA for Peachtree Proportional Head Control Unit (phc-3).
| Device ID | K991090 |
| 510k Number | K991090 |
| Device Name: | PEACHTREE PROPORTIONAL HEAD CONTROL UNIT (PHC-3) |
| Classification | Wheelchair, Powered |
| Applicant | DYNAMIC SYSTEMS, INC. 5002 N. ROYAL ATLANTA DR., #P Tucker, GA 30084 |
| Contact | David R Court |
| Correspondent | David R Court DYNAMIC SYSTEMS, INC. 5002 N. ROYAL ATLANTA DR., #P Tucker, GA 30084 |
| Product Code | ITI |
| CFR Regulation Number | 890.3860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-01 |
| Decision Date | 1999-09-24 |
| Summary: | summary |