Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
FDA 510(k) K222206 · Shenzhen Dongjilian Medical Tech Co., Ltd.
510(k) numberK222206
Submission
- Device name
- Air Compression Leg Massager (Models: S9036C, S9036B and S9036A)
- Applicant
- Shenzhen Dongjilian Medical Tech Co., Ltd.
Shenzhen, CN - Received
- July 25, 2022
- Decision date
- September 30, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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.
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|---|---|---|
| K233536 | Air Compression Recovery SystemIRP · Traditional | 12/16/2023SE |
Questions and answers
When was Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) cleared by the FDA?
Air Compression Leg Massager (Models: S9036C, S9036B and S9036A) (K222206) received a 510(k) decision of Substantially Equivalent on September 30, 2022, 67 days after the submission was received.
What is the product code of K222206?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.