Chair, Ophthalmic, Manual
The Manual Ophthalmic Chair is a specially designed examination chair providing the patient with a stable, adjustable seating position during ophthalmic examinations, allowing the clinician to position the patient appropriately at various instruments. It is classified as FDA Class 1, the lowest risk category, subject only to general controls without a premarket notification requirement. The product code is HMD, regulated under 21 CFR 886.1140, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
Research product code HMD in seconds
The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.
Free to try · every answer cites its records
Basic Information
- Product Code
- HMD
- 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 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K833538 | DOWING OPHTHALMIC CHAIR-NON/AC POWER | Mar 05, 1984 | Substantially Equivalent | Vision Health Technology |
FEI Numbers
This FDA classification entry is associated with 17 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 17 registration numbers. Click on an entry to view related FDA registrations.