← Back to catalogue

Litestream 500e

FDA 510(k)

Class I (US FDA 510(k))

510(k) K042444

by Pride Mobility Products Corp.

Identifiers

510(k) Number
K042444 FDA 510(k)
FDA Product Code
IOR FDA 510(k)

Classification

Device Class
Class I FDA 510(k)
Legislation / Framework
21 CFR Part 890.3850 FDA 510(k)
Regulation Number
890.3850 FDA 510(k)
Advisory Committee
Physical Medicine FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Litestream 500e by Pride Mobility Products Corp. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Sources (1)

  • FDA 510(k) K042444 24 fields · synced Jun 18, 2026