Splint, Pneumatic, Arm & Splint, Pneumatic, Leg

FDA 510(k)

Class I (US FDA 510(k))

510(k) K941869

Identifiers

510(k) Number: K941869 FDA 510(k)
FDA Product Code: KZF FDA 510(k)

Classification

Device Class: Class I FDA 510(k)
Legislation / Framework: 21 CFR Part 880.6320 FDA 510(k)
Regulation Number: 880.6320 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

Splint, Pneumatic, Arm & Splint, Pneumatic, Leg by The Lighthouse For the Blind, Inc. — Class I — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K941869	Class I	Active

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Manufacturer

Manufacturer: The Lighthouse For the Blind, Inc.

Sources (1)

FDA 510(k) K941869 24 fields · synced Jun 18, 2026