SPIFFY
FDA 510(k) clearance K945650 · decided 1994-12-19
Clearance details
- K-number
- K945650
- Device name
- SPIFFY
- Applicant
- Thames Valley Children'S Centre
- Decision
- Substantially Equivalent
- Date received
- 1994-11-17
- Decision date
- 1994-12-19
- Days to decision
- 32 days
- Clearance type
- Traditional
- Product code
- INN
- Device class
- 1
- Regulation number
- 890.3100
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- London Ontario N6c 5y6, CA
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| THERADAPT HIGHCHAIR/STROLLER INSERT (K942397) | Theradapt Products, Inc. | 1994-06-22 |
| THERADAPT(R) ADJUSTABLE CLASSROOM CHAIR (K930520) | Theradapt Products, Inc. | 1993-03-24 |
| ABLE GENERATION THERAPY TILT BENCH (K923753) | The Able Generation, Inc. | 1993-01-29 |
| ABLE GENERATION PLAY CHAIR (K923752) | The Able Generation, Inc. | 1993-01-29 |
| ABLE GENERATION BOOSTER CHAIR (K923750) | The Able Generation, Inc. | 1993-01-29 |
| KAYE MODEL KIAO PELVIC/THIGH STABILIZER (K923095) | Kaye Products, Inc. | 1992-07-21 |
| CHAIR, ADJUSTABLE, MECHANICAL (K922061) | Kaye Products, Inc. | 1992-05-26 |
| ACTIVITY CHAIR (K921272) | Rifton Equipment For the Handicapped | 1992-04-07 |
| BRODA NURSING CARE CHAIR (K904069) | Broda Ent., Inc. | 1990-09-17 |
| SHOWER-A-WAY (K902951) | Tri-S-Sales and Mfg. | 1990-07-25 |
| THE COMPANION NON-ELECTRIC LIFT CHAIR (K902600) | Innovative Medical Engineering, Inc. | 1990-06-21 |
| TOI-LIFT (K896814) | Mill-Tech Ent., Inc. | 1990-02-20 |
Recalls involving this device
No recalls on record reference this clearance.