Raised Chair W/Foot Platform
FDA 510(k) K812347 · Fred Sammons, Inc.
510(k) numberK812347
Submission
- Device name
- Raised Chair W/Foot Platform
- Applicant
- Fred Sammons, Inc.
Mchenry, IL, US - Received
- August 18, 1981
- Decision date
- September 11, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- INN – Chair, Adjustable, Mechanical
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 890.3100
- Specialty
- Physical Medicine
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| 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 |
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| K831548 | SplintsILH · Traditional | 06/27/1983SE |
| K831550 | Finger Boniometer BK7506KQW · Traditional | 06/24/1983SE |
| K831544 | Deluxe Traction Exercise Glove BK5035IOD · Traditional | 06/24/1983SE |
| K831543 | Adjust. WEIGHTS-BK5171-05,10,20 BeokION · Traditional | 06/24/1983SE |
| K831542 | Adjustable Polycentric Elbow HingeIQI · Traditional | 06/24/1983SE |
| K831553 | Leg Drainage Bag Strap BK6011KNX · Traditional | 06/16/1983SE |
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Questions and answers
When was Raised Chair W/Foot Platform cleared by the FDA?
Raised Chair W/Foot Platform (K812347) received a 510(k) decision of Substantially Equivalent on September 11, 1981, 24 days after the submission was received.
What is the product code of K812347?
The FDA product code is INN – Chair, Adjustable, Mechanical, a Class I (low risk) device regulated under 21 CFR 890.3100.