Romas (Range of Motion Assessment System)
FDA 510(k) K922550 · Verimed Holdings, Inc.
510(k) numberK922550
Submission
- Device name
- Romas (Range of Motion Assessment System)
- Applicant
- Verimed Holdings, Inc.
Fort Lauderdale, FL, US - Received
- May 29, 1992
- Decision date
- December 10, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KQX – Goniometer, Ac-Powered
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.1500
- Specialty
- Orthopedic
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| K971079 | Interlogics W-Tracker and Wrist Works SoftwareKQX · Traditional | Interlogics, Inc. | 07/09/1997SE |
| K962377 | 3D-SPINEKQX · Traditional | Skill Technologies, Inc. | 09/03/1996SE |
| K961212 | Spinal TouchKQX · Traditional | Fasstech | 06/12/1996SE |
| K954647 | InclinometerKQX · Traditional | J-Tech, Inc. | 10/30/1995SE |
| K943929 | Dataglove and Movement Analysis System (Mas)KQX · Traditional | Greenleaf Medical Systems, Inc. | 05/15/1995SE |
| K945630 | Large Muscle Strength GaugeKQX · Traditional | J-Tech, Inc. | 05/10/1995SE |
| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
| K940812 | Insight Electronic Alignment IndicatorKQX · Traditional | Andronic Devices, Ltd. | 11/21/1994SE |
| K925225 | The Bte Vector; Analysis System for the Low BackKQX · Traditional | Baltimore Therapeutic Equipment Co. | 06/27/1994SE |
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| K951969 | Myoexorciser II FualHCC · Traditional | 06/14/1995SE |
| K930670 | Phyaction 787IPF · Traditional | 07/02/1993SE |
| K913912 | Verimed PerineometerHIR · Traditional | 06/16/1992SE |
| K893220 | Verimed Myoexorciser VeristimIPF · Traditional | 03/07/1990SE |
| K892649 | Verimed Myoexorciser III (Myo III)HCC · Traditional | 12/13/1989SE |
| K874212 | Verimed Myo/PremsIPF · Traditional | 08/08/1988SE |
| K854193 | Electro-Myographic PerineometerHIR · Traditional | 06/09/1986SE |
| K852963 | Myo-ActuatorHCC · Traditional | 01/21/1986SE |
Questions and answers
When was Romas (Range of Motion Assessment System) cleared by the FDA?
Romas (Range of Motion Assessment System) (K922550) received a 510(k) decision of Substantially Equivalent on December 10, 1992, 195 days after the submission was received.
What is the product code of K922550?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.