Pin Dot Trunion Mounts
FDA 510(k) K913550 · Pin Dot Products, Inc.
510(k) numberK913550
Submission
- Device name
- Pin Dot Trunion Mounts
- Applicant
- Pin Dot Products, Inc.
Niles, IL, US - Received
- August 9, 1991
- Decision date
- September 5, 1991
- 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
Other 510(k)s with product code KNN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K211919 | KISS Dynamic Back Support, KISS Dynamic Solid Drop SeatKNN · Traditional | Kinetic Innovative Seating System, LLC | 03/04/2022SE |
| 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 |
| K923942 | Rhombo Medical Rhombo-FillKNN · Traditional | International Medical Products, Inc. | 03/24/1993SE |
More from International Medical Products, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K925258 | Dynamic Pressure Monitor 2000M and 2000CJFC · Traditional | 03/09/1993SE |
| K913510 | Mechanical Shape SensorJFC · Traditional | 09/23/1991SE |
| K913553 | Pin Dot Growth/Dial LinksKNN · Traditional | 09/05/1991SE |
| K913549 | Pin Dot Mounting BracketsKNN · Traditional | 09/05/1991SE |
| K913548 | Pin Dot Aluminum PanKNN · Traditional | 09/05/1991SE |
| K913546 | Impala CastersKNN · Traditional | 09/05/1991SE |
| K913545 | Pin Dot Flip-Down AbductorKNN · Traditional | 09/05/1991SE |
| K913511 | Impala AxlesKNN · Traditional | 09/05/1991SE |
| K913509 | Impala WheelsKNN · Traditional | 09/05/1991SE |
| K913507 | ArmrestKNN · Traditional | 09/05/1991SE |
Questions and answers
When was Pin Dot Trunion Mounts cleared by the FDA?
Pin Dot Trunion Mounts (K913550) received a 510(k) decision of Substantially Equivalent on September 5, 1991, 27 days after the submission was received.
What is the product code of K913550?
The FDA product code is KNN – Components, Wheelchair, a Class I (low risk) device regulated under 21 CFR 890.3920.