Company ยท US
NormaTec Industries, LP
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2026. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (1 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 6, 2026 | K261887 | Normatec Elite Heat (PRO26-SH);Normatec Elite Heat (PRO26-ST);Normatec Elite Heat (PRO26-TL);Normatec Elite Heat (PRO26- NormaTec Industries, LP | IRP |
| Sep 18, 2025 | K251905 | Normatec Elite Hip NormaTec Industries, LP | IRP |
| Mar 21, 2024 | K240122 | Normatec Elite NormaTec Industries, LP | IRP |
| Jul 14, 2022 | K221666 | Normatec Go NormaTec Industries, LP | IRP |
| Feb 25, 2022 | K220217 | Normatec 3 NormaTec Industries, LP | IRP |
| Dec 27, 2018 | K183169 | Pulse 2.0, Pulse Pro 2.0 NormaTec Industries, LP | IRP |
| Dec 21, 2018 | K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0 NormaTec Industries, LP | JOW |
| Jun 15, 2016 | K161346 | NormaTec PCD-T and PCD-B NormaTec Industries, LP | JOW |
| Apr 13, 2016 | K160608 | NormaTec Pulse and NormaTec Pulse Pro NormaTec Industries, LP | IRP |
| Jan 4, 2012 | K112890 | NORMATEC MVP NormaTec Industries, LP | IRP |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||