The following data is part of a premarket notification filed by Hi-dow International Inc. with the FDA for Pulsed Electromagnetic Field Wrap.
| Device ID | K202337 |
| 510k Number | K202337 |
| Device Name: | Pulsed Electromagnetic Field Wrap |
| Classification | Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat |
| Applicant | Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 |
| Contact | Eric Chen |
| Correspondent | Eric Chen Hi-Dow International Inc. 2555 Metro Blvd Maryland Heights, MO 63043 |
| Product Code | ILX |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-08-17 |
| Decision Date | 2020-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851640007924 | K202337 | 000 |
| 00851640007917 | K202337 | 000 |
| 00851640007900 | K202337 | 000 |
| 00081009308007 | K202337 | 000 |