The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Normatec 3.
| Device ID | K220217 |
| 510k Number | K220217 |
| Device Name: | Normatec 3 |
| Classification | Massager, Powered Inflatable Tube |
| Applicant | NormaTec Industries, LP 480 Pleasant Street, Suite A200 Watertown, MA 02472 |
| Contact | Steve Henderson |
| Correspondent | Prithul Bom REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IRP |
| CFR Regulation Number | 890.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2022-01-26 |
| Decision Date | 2022-02-25 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810050282277 | K220217 | 000 |
| 00810050281980 | K220217 | 000 |