Compression Devices, Limb
FDA 510(k) K781964 · Alba-Waldensian, Inc.
510(k) numberK781964
Submission
- Device name
- Compression Devices, Limb
- Applicant
- Alba-Waldensian, Inc.
Mchenry, IL, US - Received
- November 20, 1978
- Decision date
- December 12, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
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| K020592 | Albahealth C.A.L.M. Sleeve, Model 59001DWL · Traditional | 04/03/2002SE |
| K961405 | Alba Health Pas Wrap SystemJOW · Traditional | 12/26/1996SE |
| K852091 | Alba Dry Burn PadNAD · Traditional | 06/13/1985SE |
| K792357 | Sterile Impervious Orthopedic StockinKKX · Traditional | 12/18/1979SE |
| K780570 | Tubular Dressing RetainerFQM · Traditional | 04/19/1978SE |
| K780547 | Sterile Orthopedic StockinetteILG · Traditional | 04/10/1978SE |
| K771913 | Heel/Elbow ProtectorFMP · Traditional | 11/15/1977SE |
Questions and answers
When was Compression Devices, Limb cleared by the FDA?
Compression Devices, Limb (K781964) received a 510(k) decision of Substantially Equivalent on December 12, 1978, 22 days after the submission was received.
What is the product code of K781964?
The FDA product code is IRP – Massager, Powered Inflatable Tube, a Class II (moderate risk) device regulated under 21 CFR 890.5650.