(34 days)
No
The device description focuses on mechanical and electrical components for measuring grip and pinch strength, with no mention of AI or ML capabilities. The performance studies are standard safety and EMC tests, not related to AI/ML validation.
No
The device is used for measuring grip or pinch strength, which is a diagnostic or assessment function, not a therapeutic intervention. While the measurements can be used in rehabilitation, the device itself does not provide therapy.
Yes
The device is intended for "performing manual muscle testing to measure grip or pinch strength in an injured and uninjured," which is a diagnostic activity used to assess a patient's condition.
No
The device description explicitly details physical hardware components (hydraulic system, stainless steel gauge, rubber cap, wrist strap, handle, indicator needle) for both the hand dynamometer and pinch gauge, indicating it is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to measure grip or pinch strength for manual muscle testing. This is a physical measurement of a physiological function, not an in vitro examination of specimens derived from the human body.
- Device Description: The description details mechanical and digital components for measuring force (grip and pinch). There is no mention of analyzing biological samples or performing tests on substances outside the body.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological samples.
- Detecting or measuring specific analytes (e.g., glucose, antibodies, DNA).
- Providing information for diagnosis, monitoring, or screening based on laboratory tests.
The device is a physical measurement tool used in a clinical setting for assessing muscle strength. This falls under the category of medical devices, but not specifically In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
Product codes
LBB
Device Description
5.1 Digital Hand Dynamometer(SH5003)
In health care environment, accurate and objective data is required for reimbursable rehabilitation services, making the SAEHAN Digital Hand Dynamometer an indispensable tool.
Ideal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction.
Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service.
And a shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevents accidental damage if dropped.
The SAEHAN Digital Hand Dynamometer combines Precision with convenient features:
-Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg)
-Peak-hold needle automatically retains the highest reading until reset.
-Handle easily adjusts to five grip positions, from 1 3/8" -3 3/8", in half-inch increments.
5.2 Digital Pinch Gauge(SH5006)
Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports the weight of the gauge.
A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset.
Measures pinch force to 60 lbs. includes instructions, handy carrying case.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1(1990) was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.
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
§ 888.1240 AC-powered dynamometer.
(a)
Identification. An AC-powered dynamometer is an AC-powered device intended for medical purposes to assess neuromuscular function or degree of neuromuscular blockage by measuring, with a force transducer (a device that translates force into electrical impulses), the grip-strength of a patient's hand.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.
0
Ka52309 p/2
SEP 2 7 2005
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of 21 CFR Part 807.92.
Date: Jul 16, 2005
-
- Company and Correspondent making the submission:
Name - Saehan Corp. Address - 973, Yangdeok-Dong, Masan-City, Kyungsangnam-Do, Korea Telephone - +82-55-294-0381 Fax - +82-55-293-5019 Contact - Mrs. Tae Sun, Byun / Manager Internet - saehancorp@korea.com
- Company and Correspondent making the submission:
-
- Device :
: SH5003 Digital Hand Dynamometer Trade/proprietary name SH5006 Digital Pinch Gauge : DC-powered dynamometer Common Name : DC-powered dynamometer Classification Name
- Device :
-
- Predicate Devices :
| Manufacturer | : Ametek, Inc. |
|---|---|
| Device | : Dynamometer(FCE Series) |
| 510(k) Number | : K042889(Decision Date-Nov. 16. 2004) |
-
- Classifications Names & Citations :
21CFR 888.1240, LBB, DC-powered dynamometer, Class2
- Classifications Names & Citations :
-
- Description :
5.1 Digital Hand Dynamometer(SH5003)
- Description :
In health care environment, accurate and objective data is required for reimbursable the SAEHAN Digital Hand Dynamometer an rehabilitation services, making
1
indispensable tool.
I. Heal for routine screening of grip strength and initial and ongoing evaluation of clients with hand trauma and dysfunction.
Virtually leak-proof hydraulics and isometric design ensure accurate, reproducible results and years of reliable service.
and your of a shock-resistant rubber cap protects the stainless steel gauge and a wrist strap prevent s accidental damage if dropped.
The SAEHAN Digital Hand Dynamometer combines Precision with convenient features:
-Dual-scale readout displays isometric grip force from 0-300 lbs.(0-136 Kg)
-Peak-hold needle automatically retains the highest reading until reset.
-Handle easily adjusts to five grip position, from 1 3/8" -3 3/8", in half-inch increments.
- 5.2 Digital Pinch Gauge(SH5006)
Unlike conventional pinch gauges, The SAEHAN Digital Pinch Gauge's unique design frees the client to perform a true pinch pattern because the therapist, not the client, supports he weight of the gauge.
A highly accurate pinch-force measurement, devoid of artifact, is the result. Red indicator needle remains at maximum reading until reset.
Measures pinch force to 601bs. includes instructions, handy carrying case.
-
- Indication for use :
The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
- Indication for use :
-
- Comparison with predicate device :
Saehan Corp. believes that the SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge is substantially equivalent to Dynamometer(FCE Series) of Ametek, Inc..
- Comparison with predicate device :
-
- Safety, EMC and Performance Data :
Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1(1990) was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2001). All test results were satisfactory.
- Safety, EMC and Performance Data :
2
9. Conclusions :
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification Sachan Corp. concludes that the SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge is safe and effective and substantially equivalent to predicate devices as described herein.
-
- Sachan Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END
- Sachan Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name encircling a symbol that resembles a stylized caduceus or a representation of human figures. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" is arranged in a circular fashion around the symbol. The symbol itself consists of four abstract shapes that could be interpreted as human figures or stylized elements representing health and well-being.
Public Health Service
SEP 2 7 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sachan Corporation c/o Mr. Charlie Mack, PE Prinicipal Engineer International Regulatory Consultants 340 Shady Grove Road Flintville, Tennessee 37335
Re: K052309
KU52309
Trade/Device Name: SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge Regulation Number: 21 CFR 888.1240 Regulation Name: AC-powered dynamometer Regulatory Class: II Product Code: LBB Dated: August 20, 2005 Received: August 24, 2005
Dear Mr. Mack:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bection 9 ro(t) premained is substantially equivalent (for in indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encrosule for legally manatiment po the Medical Device Amendments, or to commerce print to May 20, 1978, the encordance with the provisions of the Federal Food. Drug.
devices that have been reclassified in accordance with the provisions of the UMA and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require appro the general controls provisions of the Act. The You may, therefore, market the act include requirements for annual registration. Ilisting of general controls provisions of the Piet 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 If your device is classified (see above) the existing major regulations affecting your device can may be subject to suen additions, Title 21, Parts 800 to 898. In addition. FDA may be found in the Outs neements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase be advised that I DA : Issuance of a vaced and other requirements of the Act that I DA has made a determination an administered by other Federal agencies. You must or any I cuttar statutes and regarations and limited to: registration and listing (21 Comply with an the Her 3 requirements (21) and manufacturing practice requirements as set a CI K Part 607); adomig (21 CFR Part 820); and if applicable. the electronic forth in the quant) bystems (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2 - Mr. Charlic Mack, PE
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter will anow you to begin mailing of substantial equivalence of your device to a legally prematice notification "Thesults 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 If you desire specific aurile 10. Jour 2010) 276-0120. 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 other general mionnational 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,
Mark A. Milliken
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
not a consultant for the 510(k) submitter]
Indications for Use
510(k) Number(if known):
Device Name: SH5003 Digital Hand Dynamometer & SH5006 Digital Pinch Gauge
Indications for Use:
The SH5003 & SH5006 Digital Hand Dynamometer & Digital Pinch Gauge are for rne Criocol or Orient.
performing manual muscle testing to measure grip or pinch strength in an injured and uninjured.
tion Use
✓
Prescription Use_ (Part 21 CFR 801 Subpart D)
Over-The-Counter Use_ AND/OR
(Part 21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation(ODE)
Mark A. Millman
Page 1 of _1
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number