DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006

K052309 · Saehan Corp. · LBB · Sep 27, 2005 · Orthopedic

Device Facts

• Record ID: K052309
• Device Name: DIGITAL HAND DYNAMOMETER, MODEL SH5003; DIGITAL PINCH GAUGE, MODEL SH5006
• Applicant: Saehan Corp.
• Product Code: LBB · Orthopedic
• Decision Date: Sep 27, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 888.1240
• Device Class: Class 2

Intended 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.

Device Story

The SH5003 Digital Hand Dynamometer and SH5006 Digital Pinch Gauge are DC-powered devices used in clinical settings for routine screening of grip strength and evaluation of hand trauma or dysfunction. The dynamometer uses a hydraulic system to measure isometric grip force (0-300 lbs), while the pinch gauge measures pinch force (up to 60 lbs). The devices feature a peak-hold function that retains the maximum force reading until reset. Clinicians operate the devices to obtain objective strength data, which informs rehabilitation progress and clinical decision-making. The dynamometer includes an adjustable handle for five grip positions. The pinch gauge design allows the therapist to support the device weight, ensuring accurate measurement without artifact. These tools provide quantitative strength metrics to assist healthcare providers in assessing patient recovery.

Clinical Evidence

Bench testing only. Performance testing conducted in accordance with EN/IEC 60601-1 (1990) for electrical, mechanical, and environmental safety, and EN/IEC 60601-1-2 (2001) for EMC. All test results were satisfactory.

Technological Characteristics

DC-powered dynamometer; hydraulic sensing mechanism; stainless steel gauge; shock-resistant rubber cap; adjustable handle (1 3/8" to 3 3/8"); digital readout with peak-hold functionality. Standards: EN/IEC 60601-1 (safety), EN/IEC 60601-1-2 (EMC).

Indications for Use

Indicated for manual muscle testing to measure grip or pinch strength in injured and uninjured patients.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Dynamometer(FCE Series) (K042889)

Submission Summary (Full Text)

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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

- 1. Company and Correspondent making the submission:
Name - Saehan Corp. Address - 973, Yangdeok-Dong, Masan-City, Kyungsangnam-Do, Korea Telephone - [phone] Fax - [phone] Contact - Mrs. Tae Sun, Byun / Manager Internet - [e-mail]

- 2. Device :
: SH5003 Digital Hand Dynamometer Trade/proprietary name SH5006 Digital Pinch Gauge : DC-powered dynamometer Common Name : DC-powered dynamometer Classification Name

- 3. Predicate Devices :

| Manufacturer | : Ametek, Inc. |
|---------------|----------------------------------------|
| Device | : Dynamometer(FCE Series) |
| 510(k) Number | : K042889(Decision Date-Nov. 16. 2004) |

- 4. Classifications Names & Citations :
21CFR 888.1240, LBB, DC-powered dynamometer, Class2

- 5. Description :
5.1 Digital Hand Dynamometer(SH5003)

In health care environment, accurate and objective data is required for reimbursable the SAEHAN Digital Hand Dynamometer an rehabilitation services, making

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#### 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.

- 6. 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.

- 7. 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..

- 8. 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.

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#### 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.

- 10. Sachan Corp. will update and include in this summary any other information deemed seasonably necessary by the FDA.
END

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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.

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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 [phone] or [phone] 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

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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