Leg Massager (Models:RP-ALM070H, RP-ALM071H)
FDA 510(k) K232965 · Shenzhen Ruiyi Business Technology Co., Ltd.
510(k) numberK232965
Submission
- Device name
- Leg Massager (Models:RP-ALM070H, RP-ALM071H)
- Applicant
- Shenzhen Ruiyi Business Technology Co., Ltd.
Shenzhen, CN - Received
- September 21, 2023
- Decision date
- November 20, 2024
- 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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|---|---|---|---|
| K260944 | ManaCold Compression SystemIRP · Traditional | Manamed, LLC | 08/12/2026SE |
| K260529 | Air Compression Massager (HY-1165)IRP · Traditional | Xiamen High Top Electronic Technology Co., Ltd. | 07/27/2026SE |
| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
| K253919 | Cryo And Thermo Therapy SystemIRP · Traditional | Xiamen Weiyou Intelligent Technology Co., Ltd. | 06/10/2026SE |
| K252396 | Cryo Sport 2.0 (AVA 501)IRP · Traditional | Avanutri Equipamentos DE Saúde | 05/29/2026SE |
| K254200 | Air Compression Leg Massager (LF-FT001, LF-FT002-1, LF-FT003, LF-FT003-1, LF-FT004-1…IRP · Traditional | Wenzhou Lingfeng Electronic Technology Co., Ltd. | 05/05/2026SE |
| 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 |
|---|---|---|
| K222924 | Leg Massager RF-ALM070IRP · Traditional | 12/23/2022SE |
Questions and answers
When was Leg Massager (Models:RP-ALM070H, RP-ALM071H) cleared by the FDA?
Leg Massager (Models:RP-ALM070H, RP-ALM071H) (K232965) received a 510(k) decision of Substantially Equivalent on November 20, 2024, 426 days after the submission was received.
What is the product code of K232965?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.