The following data is part of a premarket notification filed by Jkh Usa, Llc with the FDA for Massage Compression Boots.
| Device ID | K201645 |
| 510k Number | K201645 |
| Device Name: | Massage Compression Boots |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | JKH USA, LLC 20505 Valley Blvd. Suite 108 Walnut, CA 91789 |
| Contact | Bill Quanqin Dai |
| Correspondent | Bill Quanqin Dai JKH USA, LLC 14271 Jeffrey Rd. #246 Irvine, CA 92620 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-17 |
| Decision Date | 2020-09-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10311917137381 | K201645 | 000 |