KQX · Goniometer, Ac-Powered
Orthopedic · 21 CFR 888.1500 · Class 1
Overview
| Product Code | KQX |
|---|---|
| Device Name | Goniometer, Ac-Powered |
| Regulation | 21 CFR 888.1500 |
| Device Class | Class 1 |
| Review Panel | Orthopedic |
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.
Classification Rationale
(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.
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.
Recent Cleared Devices (20 of 33)
Showing 20 most recent of 33 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K011827 | ORTELIUS 800 | Orthoscan , Ltd. | Aug 28, 2001 | SESE |
| K971079 | INTERLOGICS W-TRACKER AND WRIST WORKS SOFTWARE | Interlogics, Inc. | Jul 9, 1997 | SESE |
| K962377 | 3D-SPINE | Skill Technologies, Inc. | Sep 3, 1996 | SESE |
| K961212 | SPINAL TOUCH | Fasstech | Jun 12, 1996 | SESE |
| K954647 | INCLINOMETER | J-Tech, Inc. | Oct 30, 1995 | SESE |
| K943929 | DATAGLOVE AND MOVEMENT ANALYSIS SYSTEM (MAS) | Greenleaf Medical Systems, Inc. | May 15, 1995 | SESE |
| K945630 | LARGE MUSCLE STRENGTH GAUGE | J-Tech, Inc. | May 10, 1995 | SESE |
| K943898 | SAUNDERS ELECTRONIC INCLINOMETER | The Saunders Group | Nov 28, 1994 | SESE |
| K940812 | INSIGHT ELECTRONIC ALIGNMENT INDICATOR | Andronic Devices, Ltd. | Nov 21, 1994 | SESE |
| K925225 | THE BTE VECTOR; ANALYSIS SYSTEM FOR THE LOW BACK | Baltimore Therapeutic Equipment Co. | Jun 27, 1994 | SESE |
| K933063 | ISOTECHNOLOGIES BACK TRACKER AND BACK WORKS SOFTWA | Isotechnologies, Inc. | Jan 27, 1994 | SESE |
| K924416 | BOOST, MICE, GAMESYS. | Penny and Giles Biometrics , Ltd. | Jun 15, 1993 | SESE |
| K922550 | ROMAS (RANGE OF MOTION ASSESSMENT SYSTEM) | Verimed Holdings, Inc. | Dec 10, 1992 | SESE |
| K920256 | SPINE MOTION ANALYZER WITH EMG | Orthopedic Systems, Inc. | Aug 10, 1992 | SESE |
| K920690 | NOROTRACK 360 INCLINOMETER | Noromed, Inc. | May 20, 1992 | SESE |
| K914062 | NK DEXTERITLY BOARD, MODEL BX001 | Nk Biotechnical Engineering Co. | Dec 9, 1991 | SESE |
| K914061 | NK RANGE OF MOTION SENSOR, MODEL RM002 | Nk Biotechnical Engineering Co. | Dec 9, 1991 | SESE |
| K914060 | RANGE OF MOTION SENSOR, MODEL RM001 | Nk Biotechnical Engineering Co. | Dec 9, 1991 | SESE |
| K913079 | 02810-01/02810-02 ORTHORANGER II/02810-3 ROM 360 | Lucas Sensing Systems, Inc. | Sep 25, 1991 | SESE |
| K897178 | DYNATRON 360 RANGE OF MOTION TESTING DEVICE | Dynatronics Corp. | Apr 18, 1990 | SESE |
Top Applicants
- Nk Biotechnical Engineering Co. — 3 clearances
- Orthopedic Systems, Inc. — 3 clearances
- Greenleaf Medical Systems, Inc. — 2 clearances
- J-Tech, Inc. — 2 clearances
- Andronic Devices, Ltd. — 1 clearance
