Question 1

Who is the manufacturer of THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER?

Accepted Answer

Measurement Specialties, Inc. filed the 510(k) submission for THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER (K010706).

Question 2

What is the FDA product code for THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER?

Accepted Answer

MNW. It is classified under 21 CFR 870.2770 as a Class 2 device in the Cardiovascular panel.

Question 3

When was THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER cleared by the FDA?

Accepted Answer

Oct 5, 2001 (decision: SESE).

Question 4

What is the regulatory pathway for THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER?

Accepted Answer

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

Question 5

Who can help prepare an FDA 510(k) submission like THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER?

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	K010706
Device Name	THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER
Applicant	Measurement Specialties, Inc.
Product Code	MNW · Cardiovascular
Decision Date	Oct 5, 2001
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2770
Device Class	Class 2

THINNER RESOLVE FITNESS MONITOR/BODY SCALE, HEALTH-O-METER

Device Facts

Regulatory Classification

Identification

Special Controls