Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

TENS-O-TEST

K-Number: K791637 · 1979-09-12

ApplicantCuromatic, Inc.
Decision Date1979-09-12
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TENS-O-TEST is the device name listed in this FDA 510(k) record. The listed applicant is Curomatic, Inc.. It received FDA 510(k) clearance on 1979-09-12 under 510(k) number K791637. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TENS-O-TEST?

TENS-O-TEST is a medical device that received FDA 510(k) clearance on 1979-09-12. The listed applicant is Curomatic, Inc.. The 510(k) number is K791637.

When did TENS-O-TEST receive FDA 510(k) clearance?

TENS-O-TEST received FDA 510(k) clearance on 1979-09-12, under 510(k) number K791637.

Who is the listed applicant for TENS-O-TEST?

The FDA 510(k) record lists Curomatic, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TENS-O-TEST?

The FDA product code for TENS-O-TEST is DXN.

Other records listing Curomatic, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K781321TENS-O-TEST

Related Devices (Code: DXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261929Upper Arm Blood pressure monitor (BP7155D)OMRON Healthcare, Inc.K254000Happy Health Blood Pressure MonitorHappy Health, Inc.K262658Automatic Digital Blood Pressure monitor (LD-526)Honsun (Nantong) Co., Ltd.K261394Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6186 Plus, DBP-6286B Plus, DBP-61E3 Plus, DBP-61E2 Plus, DBP-62E3B Plus, DBP-62E2B Plus)JOYTECH Healthcare Co., Ltd.K253425Arm-type Fully Automatic Digital Blood Pressure Monitor (DBP-6194-P,DBP-6294B-P,DBP-6195P,DBP-6295B-P, DBP-6196P,DBP-6296B-P,DBP-61E1-P, DBP-62E1B-P,DBP-62E3B-P,DBP-61E2-P,DBP-62E2B-P,DBP-61E3-P,DBP-6173-P,DBP-6273B-P,DBP-6179-P,DBP-6279B-P)Joytech Healthcare Co. , Ltd.K261061BP Go (BPP-855)Wellvii, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑