Question 1

Who is the manufacturer of QUICKIE TSR?

Accepted Answer

Sunrise Medical, Inc. filed the 510(k) submission for QUICKIE TSR (K952641).

Question 2

What is the FDA product code for QUICKIE TSR?

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 QUICKIE TSR cleared by the FDA?

Accepted Answer

Jul 6, 1995 (decision: SESE).

Question 4

What is the regulatory pathway for QUICKIE TSR?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like QUICKIE TSR?

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	K952641
Device Name	QUICKIE TSR
Applicant	Sunrise Medical, Inc.
Product Code	IOR · Physical Medicine
Decision Date	Jul 6, 1995
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 890.3850
Device Class	Class 1

QUICKIE TSR

Device Facts

Regulatory Classification

Identification