(92 days)
No
The device description explicitly states it is a "non-automated, mechanical blood pressure monitor" and relies on manual operation and a stethoscope for detecting sounds, with no mention of computational or learning capabilities.
No.
The device is used for the measurement and display of arterial blood pressure, which is a diagnostic function, not a therapeutic one. It does not treat or alleviate any medical condition.
No
The device is a non-automated, mechanical blood pressure monitor used for indirect measurement and display of arterial blood pressure. While it measures a physiological parameter, it does not interpret or analyze this data to provide a diagnosis of a disease or condition. It is a measurement tool, not a diagnostic one.
No
The device description explicitly lists physical components like an adjustable cuff, stethoscope, and a 300 mmHg gauge, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a physiological state, health, or disease.
- This device measures blood pressure indirectly and non-invasively on the human body. It does not analyze any biological samples.
The description clearly states its function is the "indirect measurement (non-invasive) and display of arterial blood pressure" using a cuff, aneroid gauge, and stethoscope. This is a classic example of a non-IVD medical device used for physiological measurement.
N/A
Intended Use / Indications for Use
The Aneroid Sphygmomanometer with Stethoscope is a non-automated, mechanical blood pressure monitor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.
Product codes
DXQ
Device Description
The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure monitor used for measuring pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds. The Aneroid Sphygmomanometer with Stethoscope contains: - Adjustable D-ring Cuff (Adult Size) - Stethoscope (Attaches to the cuff) - Non-stop rotary pin, 300 mmHg gauge - Instruction booklet and record - Carrying case. The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor blood pressure within the arteries at highest (systolic) and lowest (diastolic or relaxation) pressure. To operate, the user places the attached stethoscope on the inner arm above the bend in the elbow, to detect the pace of the brachial artery. After inflation of the cuff, the user does auscultatory monitoring with a stethoscope to evaluate systolic and diastolic pressure. These are usually recorded as a ratio of the two measurements: systolic over diastolic.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Inner arm above the bend in the elbow (for stethoscope placement to detect brachial artery)
Indicated Patient Age Range
over age 18
Intended User / Care Setting
professionals as well as trained individual users over age 18 at hospitals or at home. The device is for use in OTC.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
HONSUN(NANTONG)CO.,LTD. concludes that the subject Aneroid Sphygmomanometer with Stethoscope, Model LD-100, is as safe and effective as the predicate, Aneroid Sphygmomanometer with Stethoscope, based on the conformance to AAMI/ANSI SP10:2002/A2:2006, "Standard for Manual, automated and semi-automated Sphygmomanometers," and non-clinical mechanical testing performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1120 Blood pressure cuff.
(a)
Identification. A blood pressure cuff is a device that has an inflatable bladder in an inelastic sleeve (cuff) with a mechanism for inflating and deflating the bladder. The cuff is used in conjunction with another device to determine a subject's blood pressure.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image contains handwritten text. The text at the top appears to be "K09245". Below that, the text "P 1/2" is written. The handwriting is somewhat stylized, with the numbers and letters having a distinct, slightly irregular form.
APPENDIX #1
HONSUN(NANTONG)CO.,LTD
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in This summary of Shots) Sales) and the first & SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:
OCT 2 8 2009
Submitter's Identification: 1. Company: HONSUN(NANTONG)CO.,LTD
Add: Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA E-mail: david-zhang@lordmed.com
Contact: Mr. David Zheng
Date Summary Prepared: 7TH June 2009
Trade or Proprietary Device Name: 2
Aneroid Sphygmomanometer with Stethoscope, Model LD-100
Common or Usual Name:
Blood Pressure Kit (Blood Pressure Cuff)
Classification Name:
Cuff, Blood Pressure
Panel: Cardiovascular
Legally Marketed Predicate Device: 3.
Aneroid Sphygmomanometer with Stethoscope, K060871 WENZHOU LONGWAN
MEDICAL INSTRUMENT COMPANY
Device Description: 4.
The Aneroid Sphygmomanometer with Stethoscope is a non-invasive blood pressure The Anerold Spriygmomanomotor with on pressure levels. This Non-automated Sphygmomanometer uses an occluding cuff, an aneroid
Page 1 of 2
Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA Tel:(00)86-0513-85986718- + 614 Fax:(00)86-0513-85986716
1
Image /page/1/Picture/2 description: The image shows handwritten text. The text at the top reads "K092245". Below that, the text reads "P2/2".
Add: No8, Tongxing Road, Nantong Economic & Technological Development Area JIANGSU CHINA
Sphygmomanometer to measure pressure and a stethoscope for detecting Korotkoff sounds.
The Aneroid Sphygmomanometer with Stethoscope contains:
- Adjustable D-ring Cuff (Adult Size) 1.
- Stethoscope (Attaches to the cuff) 2.
- Non-stop rotary pin, 300 mmHg gauge 3.
- Instruction booklet and record ব
- Carrying case ട്.
The Aneroid Sphygmomanometer with Stethoscope enables the user to monitor The Arterold Sphygmomonomoter within the arteries at highest (systolic the procedio on and lowest (diastolic or relaxation) pressure.
To operate, the user places the attached stethoscope on the inner arm above the To operate, the user places the attached the brachial artery. After inflation of the cuff, berid in the elbow, to detect the pace of instethoscope to evaluate systelic and trie user does adultory moniteling was are usually recorded as a ratio of the two measurements: systolic over diastolic.
Intended Use: റ്റ്
The Aneroid Sphygmomanometer with Stethoscope is a non-automated, The Anefold Ophygmomanomettor that is used for the indirect measurement (non-invasive) and display of arterial blood pressure. It can be used by (nor-invasive) and display of archarblood procourer age 18 at hospitals or at home professionals as well as trainounting pressure. The device is for use in OTC.
Statement of Compliance to FDA Recognized Consensus Standards: ે.
The Aneroid Sphygmomanometer with Stethoscope, Model LD-100, has been The Ancroid Ophygmomananesi/AAMI AAMI / ANSI SP10:2002/A2:2006 Standard for Non-automated Sphygmomanometers.
- Conclusion: 7.
HONSUN(NANTONG)CO.,LTD. concludes that the subject Aneroid Sphygmomanometer with Stethoscope, Model LD-100, is as safe and effective as Sphygmomanometer with stomosopperer with Stethoscope, based on the predicate, Ancroid Ophygimsmar: 2006, "Standard for Manual, conformance to AAM17 ANOF OF 10.2002/1212000/ Studis as well as non-clinical mechanical testing performed.
Page 2 of 2
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure, represented by a series of curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 2 8 2009
Honsun (Nantong) Co., Ltd. c/o Mr. David Zhang Official Correspondent No8, Tongxing Road Nantong Economic & Technological Development Area Nantong, Jiangsu 226000 CHINA
K092245 Re:
Trade/Device Name: Aneroid Sphygmomanometer with Stethoscope, Model LD-100 Regulatory Number: 21 CFR 870.1120 Regulation Name: Blood Pressure Cuff Regulatory Class: II (two) Product Code: DXQ Dated: September 15, 2009 Received: October 1, 2009
Dear Mr. Zhang:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Mr. David Zhang
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807,97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Exhibit B
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of ... । ਰ Page
510(k) Number (if known):
Device Name: Aneroid Sphygmomanometer with Stethoscope Model LD-100
Indications For Use:
The Aneroid Sphygmomanometer with Stethoscope is a non-automated, The Anerold Sphyghtornanometer That is used for the indirect measurement
mechanical blood pressure monitor that is used by mechanical blood pressure monitor object pressure It can be used by (non-invasive) and display of artendr brook users over age 18 at hospitals or at
professionals as well as trained individual users over age in for use in professionals as well as trained individual assist of the device is for use in orc .
| Prescription Use | |
|---|---|
| (Per 21 CFR 801 Subpart D) |
Over-The Counter Use_x (21 CFR 807 Subpart C)
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number_
(PLEASE DO NOT WRITE BELOW PAGE IF NEEDED) -CONTINUE ON ANOTHER
Concurrence of CDRH, Office of Device Evaluation (ODE)
KO42245