The following data is part of a premarket notification filed by Med Surg Designs, Inc. with the FDA for Articular Motion Device (amd4000).
| Device ID | K863639 |
| 510k Number | K863639 |
| Device Name: | ARTICULAR MOTION DEVICE (AMD4000) |
| Classification | Exerciser, Powered |
| Applicant | MED SURG DESIGNS, INC. 124 PARKER COURT Chardon, OH 44024 |
| Contact | Thomas J Lang |
| Correspondent | Thomas J Lang MED SURG DESIGNS, INC. 124 PARKER COURT Chardon, OH 44024 |
| Product Code | BXB |
| CFR Regulation Number | 890.5380 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-09-17 |
| Decision Date | 1986-09-29 |