510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
SECClass II

Wearable Fall Injury Prevention Device

21 CFR 890.3780 / Physical Medicine
FDA source (opens on fda.gov)

SEC is the FDA product code for Wearable Fall Injury Prevention Device, a class II device type, regulated under 21 CFR 890.3780. FDA's definition for this code reads: "A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury". As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
SEC
Device name
Wearable Fall Injury Prevention Device
FDA definition
A wearable fall injury prevention device is intended to detect falls and prevent major fall injuries. Once a fall is detected, the device deploys a protective mechanism to reduce the risk of injury.
Regulation
21 CFR 890.3780
Device class
Class II
Review panel
Physical Medicine
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code SEC

By decision year
1 clearance under product code SEC with a decision year between 2025 and 2025, 2025 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code SEC by decision year
YearClearances
20251

Applicants with the most clearances

Product code SEC
Applicants holding the most 510(k) clearances under product code SEC
ApplicantClearances
Active Protective Technologies, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code