Recovery Pump, 737R (RPX)
FDA 510(k) K190493 · Mego Afek AC , Ltd.
510(k) numberK190493
Submission
- Device name
- Recovery Pump, 737R (RPX)
- Applicant
- Mego Afek AC , Ltd.
Kibbutz Afek, IL - Received
- February 28, 2019
- Decision date
- May 15, 2019
- 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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| K251622 | Hand Massager (SM004D)IRP · Traditional | Ningbo Zhenhai Yihao Electronic Technology Co.… | 01/28/2026SE |
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Questions and answers
When was Recovery Pump, 737R (RPX) cleared by the FDA?
Recovery Pump, 737R (RPX) (K190493) received a 510(k) decision of Substantially Equivalent on May 15, 2019, 76 days after the submission was received.
What is the product code of K190493?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.