Air Compressible Limb Therapy System
FDA 510(k) K150033 · Daesung Maref Co., Ltd.
510(k) numberK150033
Submission
- Device name
- Air Compressible Limb Therapy System
- Applicant
- Daesung Maref Co., Ltd.
Gunpo-Shi, KR - Received
- January 9, 2015
- Decision date
- April 20, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
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| K160178 | Lympha-Flow(LF1200)IRP · Special | 01/11/2017SE |
| K160180 | Intermittent Pneumatic Compression systemJOW · Special | 11/03/2016SE |
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Questions and answers
When was Air Compressible Limb Therapy System cleared by the FDA?
Air Compressible Limb Therapy System (K150033) received a 510(k) decision of Substantially Equivalent on April 20, 2015, 101 days after the submission was received.
What is the product code of K150033?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.