FDA product code HMD: Chair, Ophthalmic, Manual
HMD is the FDA product code for chair, ophthalmic, manual. It is a Class I device, regulated under 21 CFR 886.1140 and reviewed by the Ophthalmic panel. FDA has cleared 1 510(k) submission under HMD. The average 510(k) review took 152 days (median 152).
Classification
| Field | Value |
|---|---|
| Device name | Chair, Ophthalmic, Manual |
| Device class | Class I |
| Regulation | 21 CFR 886.1140 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every HMD clearance
Top HMD applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Vision Health Technology | 1 | 1984-03-05 |
Most recent HMD clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K833538 | Vision Health Technology | DOWING OPHTHALMIC CHAIR-NON/AC POWER | 1984-03-05 | 152 |
Recalls for HMD devices
openFDA lists no recalls for product code HMD.
Frequently asked questions
What is FDA product code HMD?
HMD is the FDA product code for chair, ophthalmic, manual. It is a Class I device, regulated under 21 CFR 886.1140 and reviewed by the Ophthalmic panel.
What device class is HMD?
Class I, regulation 21 CFR 886.1140. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code HMD?
Across 1 cleared submissions the average was 152 days from receipt to decision (median 152).
Which companies have the most HMD clearances?
Vision Health Technology (1).
Next steps
- Run an FDA pathway report with predicate devices for product code HMD
- Run a recall and safety report across every HMD manufacturer
- Watch product code HMD for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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