What is FDA product code FLL?

A continuous measurement thermometer is a clinical electronic thermometer indicated to measure the body or skin temperature of a person continuously or in specified intervals. Under this regulation, this product code represents non-exempt devices. For more information, see 90 FR 25889, available at https://www.govinfo.gov/content/pkg/FR-2025-06-18/pdf/2025-11207.pdf.

Radius PPG · Continuous Measurement Thermometer → General Hospital

Name: Radius PPG
Brand: Radius PPG

115manufacturers in China registered for this device type

1catalogue number

1510(k) clearance

Who Else Makes It

Concentrated in Guangdong (68), Zhejiang (15), Jiangsu (13). 17 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code FLL
Manufacturer	City	Province	Registered as	Device types
Amphenol Medical Technologies (Dongguan) Co., Ltd.	Dongguan	Guangdong	Contract manufacturer	77
Well Lead Medical Co., Ltd.	Guangzhou	Guangdong	Contract manufacturer	46
Zhejiang Hongyu Medical Commodity Co., Ltd.	Yiwu	Zhejiang	Contract manufacturer	36
Hochuen Medical Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	20
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Tianjin Choice Medical Device Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	12
Medwell Technology Limited	Dongguan	Guangdong	Contract manufacturer	10
Famidoc Technology Co., Ltd.	Dong Guan	Guangdong	Contract manufacturer	9
EMI (Dongguan) Asia Limited	Dongguan	Guangdong	Contract manufacturer	9
Tasco Medical Industries Co., Ltd.	Bao An District, Shenzhen	Guangdong	Contract manufacturer	6
Wuhan Strong Electronics	Wuhan	Hubei	Contract manufacturer	6
Betacera Inc.	Suzhou	Jiangsu	Contract manufacturer	3

Showing 12 of 115. All 115 manufacturers in China registered for Continuous Measurement Thermometer

Record

Regulatory record for Radius PPG
Listed by	Masimo Corporation, United States
FDA product code	FLL
Device type	Continuous Measurement Thermometer
Device class	Class 2
Regulation	21 CFR 880.2910
Establishment	Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer
510(k)	K203215
Record published	2021-10-08
Record revised	2025-12-22 (version 2)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Latex	Labelled latex-free
Label carries	lot or batch number, expiry date
Storage	Storage environment temperature -20 to 50 °C; Handling environment humidity 10 to 95 % RH; Storage environment humidity 10 to 95 % RH; Handling environment temperature -20 to 50 °C

Catalogue Numbers

Catalogue numbers for Radius PPG
Catalogue number	Size	Status
4778		In distribution

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Unimed	Unimed Medical Supplies Inc	434
Safety 1st	Dorel Juvenile Group, Inc.	180
Welch Allyn, Inc.	Welch Allyn, Inc.	66
Diagnostix™	American Diagnostic Corp.	61
DeRoyal	Deroyal Industries, Inc.	58
Braun	KAZ USA, Inc.	53
Exergen Temporal Scanner	Exergen Corporation	50
Level 1	ICU Medical, Inc	48
Famidoc	Famidoc Technology Co., Ltd.	47
Adtemp™	American Diagnostic Corp.	35
TempTraq	Blue Spark Technologies, Inc.	35
Medline	Medline Industries, Inc.	34

Showing 12 of 843. All products under Continuous Measurement Thermometer

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance	Decision date
K203215	2021-06-11

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Radius PPG