Ballancer Platinum (1222)
FDA 510(k) K230385 · Mego Afek
510(k) numberK230385
Submission
- Device name
- Ballancer Platinum (1222)
- Applicant
- Mego Afek
Kibbuts Afek, IL - Received
- February 14, 2023
- Decision date
- April 4, 2023
- 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
Other 510(k)s with product code IRP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | 02/24/2026SE |
| K072372 | Phlebopress Model 601A Compression Therapy DeviceJOW · Traditional | 11/21/2007SE |
| K060220 | PBS Model 701A Compression Therapy DeviceJOW · Special | 02/09/2006SE |
| K013331 | Lympha Press Plus DeviceJOW · Traditional | 11/30/2001SE |
| K810338 | Lympha PressJOW · Traditional | 10/20/1981SE |
Questions and answers
When was Ballancer Platinum (1222) cleared by the FDA?
Ballancer Platinum (1222) (K230385) received a 510(k) decision of Substantially Equivalent on April 4, 2023, 49 days after the submission was received.
What is the product code of K230385?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.