# K935559: Hearing Aids HB-36M, HB-36MS, HB-36MT, HI-67P, Excel-1000

- Pathway: 510(k) (Traditional)
- Applicant: Rockwin Corp.
- Decided: Jan 27, 1994 after 71 days
- Product code: ESD (Hearing Aid, Air-Conduction, Prescription)
- Device class: 1
- Regulation: 21 CFR 874.3300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Source page: https://510kreport.com/device/K935559
Methodology: https://510kreport.com/methodology