The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Normatec Mvp.
| Device ID | K112890 |
| 510k Number | K112890 |
| Device Name: | NORMATEC MVP |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | NORMATEC INDUSTRIES, LP 555 THIRTEENTH STREET, NW Washington, DC 20016 |
| Contact | Jonathan Kahan |
| Correspondent | Jonathan Kahan NORMATEC INDUSTRIES, LP 555 THIRTEENTH STREET, NW Washington, DC 20016 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817369021627 | K112890 | 000 |
| 00817369021481 | K112890 | 000 |
| 00817369021474 | K112890 | 000 |
| 00817369021467 | K112890 | 000 |
| 00817369021450 | K112890 | 000 |
| 00817369021443 | K112890 | 000 |
| 00817369021436 | K112890 | 000 |
| 00817369021429 | K112890 | 000 |
| 00817369021412 | K112890 | 000 |
| 00817369021405 | K112890 | 000 |
| 00817369021399 | K112890 | 000 |
| 00817369021382 | K112890 | 000 |
| 00817369021498 | K112890 | 000 |
| 00817369021504 | K112890 | 000 |
| 00817369021610 | K112890 | 000 |
| 00817369021603 | K112890 | 000 |
| 00817369021597 | K112890 | 000 |
| 00817369021580 | K112890 | 000 |
| 00817369021573 | K112890 | 000 |
| 00817369021566 | K112890 | 000 |
| 00817369021559 | K112890 | 000 |
| 00817369021542 | K112890 | 000 |
| 00817369021535 | K112890 | 000 |
| 00817369021528 | K112890 | 000 |
| 00817369021511 | K112890 | 000 |
| 00817369020026 | K112890 | 000 |