PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE

K961357 · Intelligent Product Limited Co. · FLL · Aug 16, 1996 · General Hospital

Device Facts

• Record ID: K961357
• Device Name: PRO-FLEX, DIGITAL THERMOMETER WITH FLEXIBLE PROBE
• Applicant: Intelligent Product Limited Co.
• Product Code: FLL · General Hospital
• Decision Date: Aug 16, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.2910
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

The Pro-Flex is a redesign of the traditional electronic thermometer with more convenient and comfortable features. It has flexible and soft probe make user comfortable in using. It also has insertion guide to prevent over insertion when use in rectal. The funnel shape of the probe is also fit the contour of baby's underarm so the tip of the probe will be in the same middle position of the armpit every time it is used.

Device Story

Electronic thermometer; pacifier-style form factor; flexible PVC probe; ABS plastic housing; metal probe cap. Designed for infant/child temperature monitoring; rectal or axillary use. Funnel-shaped probe ensures consistent axillary placement; insertion guide prevents over-insertion during rectal use. Operated by caregivers/parents. Provides digital temperature readout. Benefits include increased comfort and consistent probe positioning compared to traditional rigid thermometers.

Clinical Evidence

Bench testing only; device meets ASTM 1112-86 standard specifications for electronic thermometers.

Technological Characteristics

Materials: ABS plastic, medical-grade PVC, metal probe cap. Standard: ASTM 1112-86. Form factor: Flexible probe with insertion guide and funnel shape. Energy source: Electronic (battery-powered).

Indications for Use

Indicated for intermittent determination of patient temperature in infants and children via rectal or axillary routes.

Regulatory Classification

Identification

A clinical electronic thermometer is a device used to measure the body temperature of a patient by means of a transducer coupled with an electronic signal amplification, conditioning, and display unit. The transducer may be in a detachable probe with or without a disposable cover.

Special Controls

(1) Device is not a clinical thermometer with telethermographic functions; (2) Device is not a clinical thermometer with continuous temperature measurement functions; and (3) Appropriate analysis and testing (such as that outlined in the currently FDA-recognized editions, as appropriate, of ISO 80601-2-56, “Medical electrical equipment—Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement,” or ASTM E1965, “Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature,” or ASTM E1112, “Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature,” or ASTM E1104, “Standard Specification for Clinical Thermometer Probe Covers and Sheaths”) must validate specifications and performance of the device.

Predicate Devices

• Digital Thermometer manufactured by Micro-Ideas Instruments Co. Ltd. (K844273)

Submission Summary (Full Text)

{0}

8961357

AUG 16 1996

# Intelligent Product L.C.

463 North Orem Orem, UT 84057 Tel/Fax: [phone]

## 510(K) Summary

Submitter: Intelligent Product L. C.
Contact Person: Matthew Kho
Address: 463 North Orem Blvd., Orem, Utah 84057
Telephone: [phone]
Date of Submission: Jan 10, 1996

Classification Name: Electronic Clinical Thermometer
Common/Usual Name: Pro-Flex
Proprietary Name: Pro-Flex, Digital Pacifier Thermometer

Legally Marketed Device to which Substantial Equivalence is claimed:
Digital Thermometer manufactured by Micro-Ideas Instruments Co. Ltd. (K844273)

Pro-Flex is a redesign of the traditional electronic thermometer with more convenient and comfortable features. It has flexible and soft probe make user comfortable in using. It also has insertion guide to prevent over insertion when use in rectal. The funnel shape of the probe is also fit the contour of baby's underarm so the tip of the probe will be in the same middle position of the armpit every time it is used.

The Pro-Flex is a safe device. It is contracted to be manufactured by ISO 9001 certified manufacturer, Micro Idea Instruments Co. Ltd. who also has some FDA registered Clinical Electronic Thermometer that are legally marketed in USA (Owner ID # 8020605). It is made to meet the ASTM 1112-86, "Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature". The materials that used on Pro-Flex include ABS plastic and the metal cap on the probe are the same materials on Micro Idea's thermometer which are legally marketed in US for a period of time already. The PVC flexible probe is also medical graded and certified by AlphaGary Corporation.

In conclusion, I believe that Pro-Flex is a well designed, quality and safe device. It is also substantially equivalent to the legally marketed device listed above. I hereby submit Pro-Flex for the 510(K) approval.

Sincerely,

Matthew Kho
President.

12