The following data is part of a premarket notification filed by Mekanika, Inc. with the FDA for Mekanika's Spinal Stiffness Gauge (ssg).
| Device ID | K964933 |
| 510k Number | K964933 |
| Device Name: | MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) |
| Classification | Dynamometer, Ac-powered |
| Applicant | MEKANIKA, INC. 12500 S.W. 152ND ST. Miami, FL 33177 -1411 |
| Contact | David C Holmes |
| Correspondent | David C Holmes MEKANIKA, INC. 12500 S.W. 152ND ST. Miami, FL 33177 -1411 |
| Product Code | LBB |
| CFR Regulation Number | 888.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-10 |
| Decision Date | 1997-02-03 |