MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG)
Device Facts
| Record ID | K964933 |
|---|---|
| Device Name | MEKANIKA'S SPINAL STIFFNESS GAUGE (SSG) |
| Applicant | Mekanika, Inc. |
| Product Code | LBB · Orthopedic |
| Decision Date | Feb 3, 1997 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1240 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
