FRK · Chair, Examination And Treatment
General Hospital · 21 CFR 880.6140 · Class 1
Overview
| Product Code | FRK |
|---|---|
| Device Name | Chair, Examination And Treatment |
| Regulation | 21 CFR 880.6140 |
| Device Class | Class 1 |
| Review Panel | General Hospital |
| GMP Exempt | Yes |
Identification
A medical chair or table is a device intended for medical purposes that consists of a chair or table without wheels and not electrically powered which, by reason of special shape or attachments, such as food trays or headrests, or special features such as a built-in raising and lowering mechanism or removable arms, is intended for use of blood donors, geriatric patients, or patients undergoing treatment or examination.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 880.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (4 of 4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K896275 | JEDMED J-II CHAIR | Jedmed Instrument Co. | Dec 18, 1989 | SESE |
| K791016 | ULTICARE 2500 TREATMENT CHAIR | American Health Care Industries, Inc. | Jun 27, 1979 | SESE |
| K790955 | COVER GARD | Fem-Gard, Inc. | Jun 20, 1979 | SESE |
| K790954 | HEEL GARD | Fem-Gard, Inc. | Jun 20, 1979 | SESE |
Top Applicants
- Fem-Gard, Inc. — 2 clearances
- American Health Care Industries, Inc. — 1 clearance
- Jedmed Instrument Co. — 1 clearance
