Chair, Ophthalmic, Ac-Powered
The AC-Powered Ophthalmic Chair is an electrically powered examination chair used in ophthalmic clinical settings, offering motorized positioning adjustments to accommodate patients of varying size and mobility during comprehensive eye examinations. It is classified as FDA Class 1, the lowest risk level, subject only to general controls without a premarket notification requirement. The product code is HME, regulated under 21 CFR 886.1140, within the Ophthalmic medical specialty. No special risk flags apply to this device.
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Basic Information
- Product Code
- HME
- Device Class
- FDA class 1
- Regulation Number
- 886.1140
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 16 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K930449 | MARCO, MARCOTILT, ENCORE AND CUSTOM CHAIR | Jul 06, 1993 | Substantially Equivalent | Marco Ophthalmic, Inc. |
| K914416 | BREATH-EASY, MODIFICATION | Jun 23, 1992 | Substantially Equivalent | Icor AB |
| K894018 | RELIANCE(R) 6200 EXAMINATION CHAIR | Sep 12, 1989 | Substantially Equivalent | Reliance Medical Products, Inc. |
| K870112 | STORZ ENT/OPHTHALMIC MAXI CHAIR | Feb 12, 1987 | Substantially Equivalent | Storz Instrument Co. |
| K864574 | MAC 150E OPTHALMIC CHAIR | Dec 15, 1986 | Substantially Equivalent | Koken Mfg Company, Inc. |
| K864494 | MODEL 6500 OPTHALMIC CHAIR | Dec 15, 1986 | Substantially Equivalent | Koken Mfg Company, Inc. |
| K863728 | THE ERGOSYSTEM CHAIR | Oct 31, 1986 | Substantially Equivalent | Charles D. Bell, Inc. |
| K863008 | -OM WEST 2000 GNATUS CHAIR | Sep 24, 1986 | Substantially Equivalent | Sds Dental, Inc. |
| K853743 | TECHNA VISION, INC. ELECTRIC CHAIR | Oct 17, 1985 | Substantially Equivalent | Techna Vision |
| K853151 | RELIANCE 5000 | Sep 05, 1985 | Substantially Equivalent | F. & F. Koenigkramer |
| K853150 | RELIANCE 6100 | Sep 05, 1985 | Substantially Equivalent | F. & F. Koenigkramer |
| K853149 | RELIANCE 1000, RELIANCE 1500, RELIANCE 2000 | Sep 05, 1985 | Substantially Equivalent | F. & F. Koenigkramer |
| K842045 | WOODLYN CLASSIC EXAM. CHAIR | Jun 19, 1984 | Substantially Equivalent | Woodlyn, Inc. |
| K833539 | DOWING OPHTHALMIC CHAIR AC-POWERED | Mar 05, 1984 | Substantially Equivalent | Vision Health Technology |
| K801638 | A O CUSTOM II CHAIR AND STAND | Aug 13, 1980 | Substantially Equivalent | American Optical Corp. |
| K781801 | MAXI-CHAIR | Nov 03, 1978 | Substantially Equivalent | Surgical Mechanical Research, Inc. |
FEI Numbers
This FDA classification entry is associated with 33 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 33 registration numbers. Click on an entry to view related FDA registrations.