Mac-Multi-Adjustable Chair
FDA 510(k) K841920 · Alpha Unlimited, Inc.
510(k) numberK841920
Submission
- Device name
- Mac-Multi-Adjustable Chair
- Applicant
- Alpha Unlimited, Inc.
Mchenry, IL, US - Received
- May 10, 1984
- Decision date
- May 23, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IPL – Wheelchair, Standup
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.3900
- Specialty
- Physical Medicine
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| K853766 | Alpha Super KartINI · Traditional | 11/20/1985SE |
| K841921 | Alpha Plus 1ITI · Traditional | 05/23/1984SE |
| K841919 | Alpha Tri-KartINI · Traditional | 05/23/1984SE |
| K841912 | Alpha 4 X 4ITI · Traditional | 05/23/1984SE |
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Questions and answers
When was Mac-Multi-Adjustable Chair cleared by the FDA?
Mac-Multi-Adjustable Chair (K841920) received a 510(k) decision of Substantially Equivalent on May 23, 1984, 13 days after the submission was received.
What is the product code of K841920?
The FDA product code is IPL – Wheelchair, Standup, a Class II (moderate risk) device regulated under 21 CFR 890.3900.