The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Pulse Rx 2.0, Pulse Pro Rx 2.0.
| Device ID | K183328 |
| 510k Number | K183328 |
| Device Name: | Pulse Rx 2.0, Pulse Pro Rx 2.0 |
| Classification | Sleeve, Limb, Compressible |
| Applicant | NormaTec Industries, LP 480 Pleasant St, Suite A200 Watertown, MA 02472 |
| Contact | Albert G. Sanford |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | JOW |
| CFR Regulation Number | 870.5800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2018-11-30 |
| Decision Date | 2018-12-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810050282123 | K183328 | 000 |
| 00810050281768 | K183328 | 000 |
| 00810050281782 | K183328 | 000 |
| 00810050281805 | K183328 | 000 |
| 00810050281829 | K183328 | 000 |
| 00810050281836 | K183328 | 000 |
| 00810050281881 | K183328 | 000 |
| 00810050281898 | K183328 | 000 |
| 00810050281911 | K183328 | 000 |
| 00810050281928 | K183328 | 000 |
| 00810050281942 | K183328 | 000 |
| 00810050281959 | K183328 | 000 |
| 00810050282093 | K183328 | 000 |
| 00810050282116 | K183328 | 000 |
| 00810050281720 | K183328 | 000 |