Crutch, Ptosis
The Ptosis Crutch is a simple ophthalmic device, typically a wire or plastic attachment fitted to the frame of a patient's spectacles, that physically supports a drooping upper eyelid (ptosis) to maintain the visual field and reduce visual obstruction. 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 HJZ, regulated under 21 CFR 886.5600, within the Ophthalmic medical specialty. This device is exempt from Good Manufacturing Practice (GMP) requirements under 21 CFR Part 820.
Research product code HJZ 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
- HJZ
- Device Class
- FDA class 1
- Regulation Number
- 886.5600
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
FEI Numbers
This FDA classification entry is associated with 13 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 13 registration numbers. Click on an entry to view related FDA registrations.