FDA product code LFA: Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient)
LFA is the FDA product code for aids, speech training for the hearing impaired (battery-operated or non-patient). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel. FDA has cleared 2 510(k) submissions under LFA. The average 510(k) review took 43 days (median 43).
Classification
| Field | Value |
|---|---|
| Device name | Aids, Speech Training For The Hearing Impaired (Battery-Operated Or Non-Patient) |
| Device class | Unclassified |
| Review panel | EN — Ear, Nose and Throat |
| Medical specialty | Unknown |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LFA clearance
Top LFA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Exeter Medical Labs, Inc. | 2 | 1979-04-10 |
Most recent LFA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K790554 | Exeter Medical Labs, Inc. | EXETER LIP SEAL | 1979-04-10 | 22 |
| K781522 | Exeter Medical Labs, Inc. | THE VISUAL SPEECH AID | 1978-11-08 | 64 |
Recalls for LFA devices
openFDA lists no recalls for product code LFA.
Frequently asked questions
What is FDA product code LFA?
LFA is the FDA product code for aids, speech training for the hearing impaired (battery-operated or non-patient). It is a Unclassified device, reviewed by the Ear, Nose and Throat panel.
What device class is LFA?
Unclassified. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LFA?
Across 2 cleared submissions the average was 43 days from receipt to decision (median 43).
Which companies have the most LFA clearances?
Exeter Medical Labs, Inc. (2).
Next steps
- Run an FDA pathway report with predicate devices for product code LFA
- Run a recall and safety report across every LFA manufacturer
- Watch product code LFA 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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