Rhombo Medical Rhombo-Fill
FDA 510(k) K923942 · International Medical Products, Inc.
510(k) numberK923942
Submission
- Device name
- Rhombo Medical Rhombo-Fill
- Applicant
- International Medical Products, Inc.
Minneapolis, MN, US - Received
- August 5, 1992
- Decision date
- March 24, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KNN – Components, Wheelchair
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3920
- Specialty
- Physical Medicine
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| K942311 | Dynasty U1-33 AgmKNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942310 | Dynasty GC 12550 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942309 | Dynasty U1-31 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942308 | Dynasty GC 12400 (Gell/Cell)KNN · Traditional | Foley & Lardner | 11/07/1994SE |
| K942312 | Alden Lineage Wheelchair CushionKNN · Traditional | Lewis W. Ward | 05/26/1994SE |
| K942260 | Alden Wheelchair CushionKNN · Traditional | Ward and Assoc. | 05/26/1994SE |
| K933051 | Zero Gravity Wheelchair Components, ModificationKNN · Traditional | General Components Intl., Inc. | 10/12/1993SE |
| K925980 | PMKNN · Traditional | Pathfinder Intl. Corp. | 03/24/1993SE |
| K923364 | Tilt Adjustable Sliding Back Recline Seating SystKNN · Traditional | Labac Systems, Inc. | 03/22/1993SE |
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Questions and answers
When was Rhombo Medical Rhombo-Fill cleared by the FDA?
Rhombo Medical Rhombo-Fill (K923942) received a 510(k) decision of Substantially Equivalent on March 24, 1993, 231 days after the submission was received.
What is the product code of K923942?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.