FDA product code HJZ: Crutch, Ptosis
HJZ is the FDA product code for crutch, ptosis. It is a Class I device, regulated under 21 CFR 886.5600 and reviewed by the Ophthalmic panel. Devices under HJZ reach the market by 510(k) exempt; FDA lists no cleared 510(k)s for it.
Classification
| Field | Value |
|---|---|
| Device name | Crutch, Ptosis |
| Device class | Class I |
| Regulation | 21 CFR 886.5600 |
| Review panel | OP — Ophthalmic |
| Medical specialty | Ophthalmic |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Recalls for HJZ devices
openFDA lists no recalls for product code HJZ.
Frequently asked questions
What is FDA product code HJZ?
HJZ is the FDA product code for crutch, ptosis. It is a Class I device, regulated under 21 CFR 886.5600 and reviewed by the Ophthalmic panel.
What device class is HJZ?
Class I, regulation 21 CFR 886.5600. Typical premarket route: 510(k) exempt.
Next steps
- Run an FDA pathway report with predicate devices for product code HJZ
- Run a recall and safety report across every HJZ manufacturer
- Watch product code HJZ 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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