Question 1

Who is the manufacturer of BENTLEY MANUALLY OPERATED WHEELCHAIR?

Accepted Answer

Pdg Product Design Group, Inc. filed the 510(k) submission for BENTLEY MANUALLY OPERATED WHEELCHAIR (K970311).

Question 2

What is the FDA product code for BENTLEY MANUALLY OPERATED WHEELCHAIR?

Accepted Answer

IOR. It is classified under 21 CFR 890.3850 as a Class 1 device in the Physical Medicine panel.

Question 3

When was BENTLEY MANUALLY OPERATED WHEELCHAIR cleared by the FDA?

Accepted Answer

Feb 14, 1997 (decision: SESE).

Question 4

What is the regulatory pathway for BENTLEY MANUALLY OPERATED WHEELCHAIR?

Accepted Answer

510(k) clearance (submission type: Traditional).

Question 5

Who can help prepare an FDA 510(k) submission like BENTLEY MANUALLY OPERATED WHEELCHAIR?

Accepted Answer

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Record ID	K970311
Device Name	BENTLEY MANUALLY OPERATED WHEELCHAIR
Applicant	Pdg Product Design Group, Inc.
Product Code	IOR · Physical Medicine
Decision Date	Feb 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3850
Device Class	Class 1

BENTLEY MANUALLY OPERATED WHEELCHAIR

Device Facts

Regulatory Classification

Identification