Talley TM500 Sequential Multicom Compression Syst.
FDA 510(k) K915637 · Progressive Medical Technology, Inc.
510(k) numberK915637
Submission
- Device name
- Talley TM500 Sequential Multicom Compression Syst.
- Applicant
- Progressive Medical Technology, Inc.
Lansing, MI, US - Received
- December 17, 1991
- Decision date
- February 11, 1992
- 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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| K260948 | Air Compression Massager (EP30B001 I)IRP · Traditional | Wavepulse (Xiamen) Healthcare Technology Co., Ltd. | 07/24/2026SE |
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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.
| 510(k) | Device | Decision |
|---|---|---|
| K923710 | Oscillair 3000 Low Air Loss Kinetic Therapy BedIKZ · Traditional | 03/22/1993SE |
| K915638 | Talley TM200 Intermttent Compression UnitIRP · Traditional | 02/11/1992SE |
| K915092 | Talley TM300 Sequential Multicom Compression SystIRP · Traditional | 02/11/1992SE |
| K915671 | B.A.S.E. Bellows Air Support EquipmentIOQ · Traditional | 01/13/1992SE |
Questions and answers
When was Talley TM500 Sequential Multicom Compression Syst. cleared by the FDA?
Talley TM500 Sequential Multicom Compression Syst. (K915637) received a 510(k) decision of Substantially Equivalent on February 11, 1992, 56 days after the submission was received.
What is the product code of K915637?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.