Normatec Elite Hip
FDA 510(k) K251905 · NormaTec Industries, LP
510(k) numberK251905
Submission
- Device name
- Normatec Elite Hip
- Applicant
- NormaTec Industries, LP
Watertown, MA, US - Received
- June 20, 2025
- Decision date
- September 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- IRP – Massager, Powered Inflatable Tube
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5650
- Specialty
- Physical Medicine
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| K253064 | Air Pressure Therapy System (VU-IPC8M); Air Pressure Therapy System (VU-IPC6M); Air…IRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 04/30/2026SE |
| K252386 | Hot and Cold Compression System (A02-C-032)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/03/2026SE |
| K253076 | Cryopush Cold Compression Device (A02-P-001)IRP · Traditional | Chengdu Cryo-Push Medical Technology Co.,Ltd | 04/02/2026SE |
| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
More from Ningbo Zhenhai Yihao Electronic Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K240122 | Normatec EliteIRP · Traditional | 03/21/2024SE |
| K221666 | Normatec GoIRP · Traditional | 07/14/2022SE |
| K220217 | Normatec 3IRP · Traditional | 02/25/2022SE |
| K183169 | Pulse 2.0, Pulse Pro 2.0IRP · Traditional | 12/27/2018SE |
| K183328 | Pulse Rx 2.0, Pulse Pro Rx 2.0JOW · Traditional | 12/21/2018SE |
| K161346 | NormaTec PCD-T and PCD-BJOW · Traditional | 06/15/2016SE |
| K160608 | NormaTec Pulse and NormaTec Pulse ProIRP · Traditional | 04/13/2016SE |
| K112890 | Normatec MVPIRP · Traditional | 01/04/2012SE |
Questions and answers
When was Normatec Elite Hip cleared by the FDA?
Normatec Elite Hip (K251905) received a 510(k) decision of Substantially Equivalent on September 18, 2025, 90 days after the submission was received.
What is the product code of K251905?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.