Normatec Go
Massager, Powered Inflatable Tube
NormaTec Industries, LP
The following data is part of a premarket notification filed by Normatec Industries, Lp with the FDA for Normatec Go.
Pre-market Notification Details
| Device ID | K221666 |
| 510k Number | K221666 |
| Device Name: | Normatec Go |
| 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 | 2022-06-08 |
| Decision Date | 2022-07-14 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00810050283793 | K221666 | 000 |
| 00810050283700 | K221666 | 000 |
Trademark Results [Normatec Go]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 NORMATEC GO 90086333 not registered Live/Pending |
NormaTec Industries, LP 2020-07-31 |
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