NormaTec Industries, LP
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 9
- Inspections
- 2
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251905 | Normatec Elite Hip | September 18, 2025 |
| K240122 | Normatec Elite | March 21, 2024 |
| K221666 | Normatec Go | July 14, 2022 |
| K220217 | Normatec 3 | February 25, 2022 |
| K183169 | Pulse 2.0, Pulse Pro 2.0 | December 27, 2018 |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 | December 21, 2018 |
| K161346 | NormaTec PCD-T and PCD-B | June 15, 2016 |
| K160608 | NormaTec Pulse and NormaTec Pulse Pro | April 13, 2016 |
| K112890 | NORMATEC MVP | January 4, 2012 |