The following data is part of a premarket notification filed by Promedtek Inc. with the FDA for Promedtek Model C1400 Shortwave Diathermy Device.
| Device ID | K162240 |
| 510k Number | K162240 |
| Device Name: | ProMedTek Model C1400 Shortwave Diathermy Device |
| Classification | Diathermy, Shortwave, For Use In Applying Therapeutic Deep Heat |
| Applicant | PROMEDTEK INC. 4110 N. SCOTTSDALE RD., SUITE 270 Scottsdale, AZ 85251 |
| Contact | Dan Puchek |
| Correspondent | Diane Horwitz MANDELL HORWITZ CONSULTANTS LLC 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Product Code | IMJ |
| CFR Regulation Number | 890.5290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-09 |
| Decision Date | 2016-11-17 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850886008016 | K162240 | 000 |
| 00850886008009 | K162240 | 000 |