The following data is part of a premarket notification filed by Nk Biotechnical Engineering Co. with the FDA for Nk Range Of Motion Sensor, Model Rm002.
| Device ID | K914061 |
| 510k Number | K914061 |
| Device Name: | NK RANGE OF MOTION SENSOR, MODEL RM002 |
| Classification | Goniometer, Ac-powered |
| Applicant | NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Contact | Karen Gotfredson |
| Correspondent | Karen Gotfredson NK BIOTECHNICAL ENGINEERING CO. P.O. BOX 26335 Minneapolis, MN 55426 |
| Product Code | KQX |
| CFR Regulation Number | 888.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-10 |
| Decision Date | 1991-12-09 |