The following data is part of a premarket notification filed by Gait-aid, Inc. with the FDA for Gait-aid Orthopedic Insole.
| Device ID | K874502 |
| 510k Number | K874502 |
| Device Name: | GAIT-AID ORTHOPEDIC INSOLE |
| Classification | Orthosis, Limb Brace |
| Applicant | GAIT-AID, INC. 4195 DUNDAS STREET WEST SUITE 303, TORONTO (ETOBICOKE) Ontario, Canada, CA M8x 1y4 |
| Contact | Duncan A Mackillop |
| Correspondent | Duncan A Mackillop GAIT-AID, INC. 4195 DUNDAS STREET WEST SUITE 303, TORONTO (ETOBICOKE) Ontario, Canada, CA M8x 1y4 |
| Product Code | IQI |
| CFR Regulation Number | 890.3475 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-02 |
| Decision Date | 1987-11-30 |