Geratherm SolarTherm Speed Digital Thermometer

FDA UDI

Class II (US FDA UDI)

by R.g. Enterprises (u.s.a.), Inc.

Identity

Trade Name: Geratherm SolarTherm Speed Digital Thermometer FDA UDI
Generic Name: Intermittent electronic patient thermometer FDA UDI
Device Name: SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided. FDA UDI
Model / Reference: Retail SolarTherm Digital Thermomete FDA UDI
Description: SolarTherm Speed digital flex tip thermometer is white with blue accent colors and is used to measure body temperatures orally, rectally or axillary. The temperature measuring range is from 89.6°~111.0°F. If the reading is below 89.6°F, the letter L will be displayed indicating Low reading. If the reading is above 111.0°F, the letter H will be displayed indicating High reading. Energy is supplied using an integrated solar cell with approximately 25 temperature readings within 60-minutes before a recharge is needed. There is an audible beeping for 8 seconds after peak temperature is reached, built-in memory recall enabling display of the previously measured and automatic shut-off in about 9 minutes. Prior to using the solar cell must be exposed to a light source at least 3 hours. This may be in room light or sunlight. A half circle symbol will appear in the display when the solar cell needs to be recharged. Turn the power off before recharging, the solar cell should face the light source during recharging and for ongoing use store on counter top where thermometer is exposed to light throughout the day. A clear plastic cover is provided. FDA UDI

Identifiers

Catalog Number: 40053 FDA UDI
Primary DI / UDI-DI: 00614801400534 FDA UDI
510(k) Number: K903590 FDA UDI
FDA Product Code: FLL FDA UDI
GMDN Term: Intermittent electronic patient thermometer FDA UDI

Classification

Device Class: Class II FDA UDI
Regulation Number: 880.2910 FDA UDI
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

FDA UDI

Single Use

Yes

FDA UDI

Implantable

FDA UDI

Contains Latex

FDA UDI

Prescription Use

FDA UDI

Over-the-Counter

Yes

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Category: Intermittent electronic patient thermometer

Geratherm SolarTherm Speed Digital Thermometer by R.g. Enterprises (u.s.a.), Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Intermittent electronic patient thermometer.

CVS Health — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
Amico Diagnostic Station — Amico Diagnostic Incorporated · Class II
ESSEF — Hangzhou Hua'An Medical & Health Instruments Co., · Class II
Rongfeng — Shen Zhen Rong Feng Technology Co., Ltd. · Class II
iProvèn — Masena Invest B.V. · Class II
Rite Aid — 180 INNOVATIONS LLC · Class II
Family Wellness — Family Dollar Stores · Class II
up&up — TARGET CORPORATION · Class II

Cleared under the same submission

K903590 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Source	Region	Type	Cert / Approval No.	Class	Status
FDA UDI	United States	FDA UDI	Registered in GUDID	Class II	Pending data

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: R.g. Enterprises (u.s.a.), Inc.

Sources (1)

FDA UDI 590edd0b-b422-4985-b9cb-e31f5baee8af 36 fields · synced May 31, 2026