Spiffy
FDA 510(k) K945650 · Thames Valley Children'S Centre
510(k) numberK945650
Submission
- Device name
- Spiffy
- Applicant
- Thames Valley Children'S Centre
London Ontario N6c 5y6, CA - Received
- November 17, 1994
- Decision date
- December 19, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- INN – Chair, Adjustable, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3100
- Specialty
- Physical Medicine
Other 510(k)s with product code INN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K942397 | Theradapt Highchair/Stroller InsertINN · Traditional | Theradapt Products, Inc. | 06/22/1994SE |
| K930520 | Theradapt(R) Adjustable Classroom ChairINN · Traditional | Theradapt Products, Inc. | 03/24/1993SE |
| K923753 | Able Generation Therapy Tilt BenchINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923752 | Able Generation Play ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923750 | Able Generation Booster ChairINN · Traditional | The Able Generation, Inc. | 01/29/1993SE |
| K923095 | Kaye Model Kiao Pelvic/Thigh StabilizerINN · Traditional | Kaye Products, Inc. | 07/21/1992SE |
| K922061 | Chair, Adjustable, MechanicalINN · Traditional | Kaye Products, Inc. | 05/26/1992SE |
| K921272 | Activity ChairINN · Traditional | Rifton Equipment For the Handicapped | 04/07/1992SE |
| K904069 | Broda Nursing Care ChairINN · Traditional | Broda Ent., Inc. | 09/17/1990SE |
| K902951 | Shower-A-WayINN · Traditional | Tri-S-Sales and Mfg. | 07/25/1990SE |
Questions and answers
When was Spiffy cleared by the FDA?
Spiffy (K945650) received a 510(k) decision of Substantially Equivalent on December 19, 1994, 32 days after the submission was received.
What is the product code of K945650?
The FDA product code is INN – Chair, Adjustable, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3100.