NK Pinch Sensor, Model PF002
FDA 510(k) K914056 · Nk Biotechnical Engineering Co.
510(k) numberK914056
Submission
- Device name
- NK Pinch Sensor, Model PF002
- 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
- LBB – Dynamometer, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 888.1240
- Specialty
- Orthopedic
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| K073154 | Facts Hand and Pinch Grip ComboLBB · Traditional | Global Services Group, LLC | 02/14/2008SE |
| K052309 | Digital Hand Dynamometer, Model SH5003; Digital Pinch Gauge, Model SH5006LBB · Traditional | Saehan Corp. | 09/27/2005SE |
| K042889 | Dynamometer - Model Fce and Model MSCLBB · Traditional | Ametek | 11/16/2004SE |
| K012492 | Kadance 2000LBB · Traditional | Kada Research, Inc. | 11/02/2001SE |
| K981730 | Digit-Grip with LCD, Model Number DGR 002LBB · Traditional | Nk Biotechnical Corp. | 07/17/1998SE |
| K980363 | Oro-Facial Myographic Measurement Instrument (Ommi)LBB · Traditional | Orofacial Dynamics | 04/16/1998SE |
| K964933 | Mekanika's Spinal Stiffness Gauge (SSG)LBB · Traditional | Mekanika, Inc. | 02/03/1997SE |
| K964685 | DynamometerLBB · Traditional | John Chatillon & Sons, Inc. | 01/27/1997SE |
| K935757 | Greenleaf Eval System/ Greenleaf SolosystemLBB · Traditional | Greenleaf Medical Systems, Inc. | 04/15/1994SE |
More from Greenleaf Medical Systems, Inc.
| 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 |
| K914061 | NK Range of Motion Sensor, Model RM002KQX · 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 |
Questions and answers
When was NK Pinch Sensor, Model PF002 cleared by the FDA?
NK Pinch Sensor, Model PF002 (K914056) 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 K914056?
The FDA product code is LBB – Dynamometer, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 888.1240.