NK Range of Motion Sensor, Model RM002
FDA 510(k) K914061 · Nk Biotechnical Engineering Co.
510(k) numberK914061
Submission
- Device name
- NK Range of Motion Sensor, Model RM002
- Applicant
- Nk Biotechnical Engineering Co.
Minneapolis, MN, US - Received
- September 10, 1991
- Decision date
- December 9, 1991
- 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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| K943898 | Saunders Electronic InclinometerKQX · Traditional | The Saunders Group | 11/28/1994SE |
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More from Baltimore Therapeutic Equipment Co.
| 510(k) | Device | Decision |
|---|---|---|
| K934368 | NK Pressure-Specified Sensory Device, Model PSSD-001LLN · Traditional | 08/11/1994SE |
| K923965 | NK Grasp Sensor, Model GA002LBB · Traditional | 05/12/1993SE |
| K923964 | NK Grasp Sensor, Model GA001LBB · Traditional | 05/12/1993SE |
| K923963 | NK Digi-Grip Sensor, Model DGR001LBB · Traditional | 03/31/1993SE |
| K921268 | NK Dyna-Grip Sensor, Model DG001LBB · Traditional | 07/14/1992SE |
| K921266 | NK Medical Micrometer, Model MC001KTZ · Traditional | 07/14/1992SE |
| K914062 | NK Dexteritly Board, Model BX001KQX · Traditional | 12/09/1991SE |
| K914060 | Range of Motion Sensor, Model RM001KQX · Traditional | 12/09/1991SE |
| K914059 | NK Deviation Sensor, Model DV001LBB · Traditional | 12/09/1991SE |
| K914057 | NK Pinch Sensor, Model PA001LBB · Traditional | 12/09/1991SE |
Questions and answers
When was NK Range of Motion Sensor, Model RM002 cleared by the FDA?
NK Range of Motion Sensor, Model RM002 (K914061) received a 510(k) decision of Substantially Equivalent on December 9, 1991, 90 days after the submission was received.
What is the product code of K914061?
The FDA product code is KQX – Goniometer, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 888.1500.