The following data is part of a premarket notification filed by North Atlantic Rehabilitation, Inc, with the FDA for Actic 2002.
| Device ID | K946169 |
| 510k Number | K946169 |
| Device Name: | ACTIC 2002 |
| Classification | Exerciser, Powered |
| Applicant | NORTH ATLANTIC REHABILITATION, INC, 2021 BARTON AVENUE #207 West Bend, WI 53095 |
| Contact | Paul Schmidt |
| Correspondent | Paul Schmidt NORTH ATLANTIC REHABILITATION, INC, 2021 BARTON AVENUE #207 West Bend, WI 53095 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-12-19 |
| Decision Date | 1995-06-15 |