Intermittent Compression System Model 5000
FDA 510(k) K930526 · Advanced Instruments, Inc.
510(k) numberK930526
Submission
- Device name
- Intermittent Compression System Model 5000
- Applicant
- Advanced Instruments, Inc.
Norwood, MA, US - Received
- February 2, 1993
- Decision date
- November 18, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JOW – Sleeve, Limb, Compressible
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5800
- Specialty
- Cardiovascular
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| K253386 | DVT GarmentJOW · Traditional | Vistar Medical Supplies Co., Ltd. | 06/25/2026SE |
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| K254267 | NanoPress 760A-BT (760A-BT)JOW · Traditional | Mego Afek , Ltd. | 02/24/2026SE |
| K250974 | Bio Arterial Deluxe (IC-BAP-DX)JOW · Traditional | Bio Compression Systems, Inc. | 12/12/2025SE |
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| K251466 | VenAir, Sequential Compression System (9P-089000); VenAir, Sequential Compression System…JOW · Special | Wellell, Inc. | 10/28/2025SE |
| K251446 | PlasmaFlow X Compression Sleeve Device (XPF0001)JOW · Special | Manamed, LLC | 09/17/2025SE |
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Questions and answers
When was Intermittent Compression System Model 5000 cleared by the FDA?
Intermittent Compression System Model 5000 (K930526) received a 510(k) decision of Substantially Equivalent on November 18, 1993, 289 days after the submission was received.
What is the product code of K930526?
The FDA product code is JOW – Sleeve, Limb, Compressible, a Class II (moderate risk) device regulated under 21 CFR 870.5800.