Chair, Examination And Treatment
An examination and treatment chair is an adjustable clinical seating device designed to support patients during medical examinations and minor procedures, providing access and stability for both clinician and patient. It is classified as FDA Class 1 (lowest risk), subject to general controls only, and does not require premarket notification. The product code is FRK, regulated under 21 CFR 880.6140, within the General Hospital medical specialty. This device is exempt from GMP requirements.
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Basic Information
- Product Code
- FRK
- Device Class
- FDA class 1
- Regulation Number
- 880.6140
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 4 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K896275 | JEDMED J-II CHAIR | Dec 18, 1989 | Substantially Equivalent | Jedmed Instrument Co. |
| K791016 | ULTICARE 2500 TREATMENT CHAIR | Jun 27, 1979 | Substantially Equivalent | American Health Care Industries, Inc. |
| K790955 | COVER GARD | Jun 20, 1979 | Substantially Equivalent | Fem-Gard, Inc. |
| K790954 | HEEL GARD | Jun 20, 1979 | Substantially Equivalent | Fem-Gard, Inc. |
FEI Numbers
This FDA classification entry is associated with 69 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 69 registration numbers. Click on an entry to view related FDA registrations.