Flexion Mittens
FDA 510(k) K771030 · Stat Medical Corp.
510(k) numberK771030
Submission
- Device name
- Flexion Mittens
- Applicant
- Stat Medical Corp.
Mchenry, IL, US - Received
- June 9, 1977
- Decision date
- June 27, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- IOD – Components, Exercise
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.5350
- Specialty
- Physical Medicine
Other 510(k)s with product code IOD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | Fred Sammons, Inc. | 06/24/1983SE |
| K823648 | Surgical TubingIOD · Traditional | Fred Sammons, Inc. | 01/21/1983SE |
| K823822 | Ankle WeightsIOD · Traditional | Danek Medical, Inc. | 01/14/1983SE |
| K823600 | Solid Wood ConeIOD · Traditional | Fred Sammons, Inc. | 12/22/1982SE |
| K813632 | Color Coded Weight CuffsIOD · Traditional | Fred Sammons, Inc. | 01/19/1982SE |
| K812319 | Therapy BenchIOD · Traditional | Kaye Products, Inc. | 08/31/1981SE |
| K790587 | Canvas WedgeIOD · Traditional | Maddak, Inc. | 04/03/1979SE |
| K772414 | Sandbags, Various WeightsIOD · Traditional | Fred Sammons, Inc. | 02/01/1978SE |
| K761119 | Sheet Metal ClampIOD · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
| K761118 | Hand Screw ClampIOD · Traditional | Fred Sammons, Inc. | 12/02/1976SE |
More from Fred Sammons, Inc.
Questions and answers
When was Flexion Mittens cleared by the FDA?
Flexion Mittens (K771030) received a 510(k) decision of Substantially Equivalent on June 27, 1977, 18 days after the submission was received.
What is the product code of K771030?
The FDA product code is IOD – Components, Exercise, a Class I (low risk) device regulated under 21 CFR 890.5350.