The following data is part of a premarket notification filed by Orthopedic Technology Research, Inc. with the FDA for Accutred Shoe.
| Device ID | K991313 |
| 510k Number | K991313 |
| Device Name: | ACCUTRED SHOE |
| Classification | Device, Warning, Overload, External Limb, Powered |
| Applicant | ORTHOPEDIC TECHNOLOGY RESEARCH, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
| Contact | Cheryl G Dyer |
| Correspondent | Cheryl G Dyer ORTHOPEDIC TECHNOLOGY RESEARCH, INC. 4717 ADAMS RD. P.O. BOX 489 Hixson, TN 37343 |
| Product Code | IRN |
| CFR Regulation Number | 890.5575 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-04-16 |
| Decision Date | 1999-06-23 |