02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360
Device Facts
| Record ID | K913079 |
|---|---|
| Device Name | 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 |
| Applicant | Lucas Sensing Systems, Inc. |
| Product Code | KQX · Orthopedic |
| Decision Date | Sep 25, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 888.1500 |
| Device Class | Class 1 |
Regulatory Classification
Identification
A goniometer is an AC-powered or battery powered device intended to evaluate joint function by measuring and recording ranges of motion, acceleration, or forces exerted by a joint.
Special Controls
*Classification.* (1) Class I (general controls) for a goniometer that does not use electrode lead wires and patient cables. This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.(2) Class II (special controls) for a goniometer that uses electrode lead wires and patient cables. The special controls consist of: (i) The performance standard under part 898 of this chapter, and (ii) The guidance entitled “Guidance on the Performance Standard for Electrode Lead Wires and Patient Cables.” This device is exempt from the premarket notification procedures of subpart E of part 807 of this chapter subject to § 888.9.
