The following data is part of a premarket notification filed by Quality Electrodynamics, Llc with the FDA for 8ch Knee-foot Speeder.
| Device ID | K162946 |
| 510k Number | K162946 |
| Device Name: | 8ch Knee-Foot SPEEDER |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | QUALITY ELECTRODYNAMICS, LLC 700 BETA DRIVE SUITE 100 Mayfield Village, OH 44143 |
| Contact | Kathleen Aras |
| Correspondent | Kathleen Aras QUALITY ELECTRODYNAMICS, LLC 6655 BETA DRIVE, SUITE 100 Mayfield Village, OH 44143 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-10-21 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814848020126 | K162946 | 000 |