(97 days)
The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: :
- Stroke rehabilitation by muscle re-education
- Maintaining or increasing range of motion
The Able-X is an exercise system that uses virtual reality to promote therapeutic bilateral movement exercises through use of a wireless hand held game controller and computer games. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X therapeutic exercise games are provide on a CD or can be downloaded directly through the internet. The Able-X does not include a separate console and is intended to be operated directly through a user supplied computer that meets minimum processing and operating system requirements.
The provided text states, "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." However, it does not provide specific acceptance criteria or detailed study results with quantitative performance data. The device is cleared based on substantial equivalence to predicate devices, rather than meeting specific performance metrics from a dedicated study.
Therefore, many of the requested details cannot be extracted from the provided text.
Here's a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the Able-X device itself. The basis for clearance is "substantial equivalence" to predicate devices.
- Reported Device Performance: The text generally states: "Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices." No specific metrics (e.g., accuracy, sensitivity, range of motion improvement percentage) are provided.
| Metric | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Not Explicitly Stated) |
|---|---|---|
| N/A | N/A (Substantial equivalence to predicates) | "Can be used according to its intended use and in an equivalent manner to the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified.
- Data Provenance: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as no specific test set requiring expert ground truth is described.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no specific test set requiring adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC study is not mentioned. This device is not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is an exercise system; the concept of "standalone performance" as typically applied to algorithms is not directly relevant here. Its performance is inherent in its function as an exercise aid.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no specific ground truth for performance metrics is described. The clearance is based on substantial equivalence, implying that its functional characteristics were deemed sufficiently similar to existing devices.
8. The sample size for the training set
- Not applicable. This device is an exercise hardware/software system, not a machine learning algorithm that requires a training set in the typical sense.
9. How the ground truth for the training set was established
- Not applicable for the same reason as above.
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K120783 PAGE I OF 2
SECTION 2.
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
2. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
JUN 2 0 2012
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
APPLICANT
lm-Able Ltd 2nd Floor, 92 Queens Drive Lower Hutt, New Zealand http://www.im-able.com/ Tel. +64-4-909 7304 Fax. +64-4-589 9533
OFFICIAL CORRESPONDENT Sigi Caron MedTech Consultants, Inc. · 2400 Via Carrillo Palos Verdes Estates, CA 90274 sigi(@medtechconsultants.com Tel: (310) 377-3069 Fax: (310) 265-7618
· Non-powered exercise equipment
TRADE NAME
Able-X
COMMON NAME
DEVICE CLASSIFICATION
Name: Non-measuring exercise equipment Regulation No: 890,5370 Product Code: ION Class: I Panel: Physical Medicine
PREDICATE DEVICE
- 트 Encore Path's BatRac (TailWind) 프 Accelerated Care Plus Corporation's OmniVR Virtual Reality Rehabilitation System
SUBSTANTIALLY EQUIVALENT TO:
The Able-X device is substantially equivalent in intended use and technological features to Encore Path's BatRac (TailWind), a Class I exempt device under 21 CFR §890.5370, and Accelerated Care Plus (ACP) Corporation's OmniVR Virtual Reality Rehabilitation System, a Class I exempt device under 21 CFR §890.5370.
DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION:
The Able-X is an exercise system that uses virtual reality to promote therapeutic bilateral movement exercises through use of a wireless hand held game controller and computer games. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless
I'm Able, Ltd. Able X: Stroke Rehabilitation Aid Traditional 510(k) Page 18 of 236
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SECTION 2. 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X therapeutic exercise games are provide on a CD or can be downloaded directly through the internet. The Able-X does not include a separate console and is intended to be operated directly through a user supplied computer that meets minimum processing and operating system requirements.
INDICATIONS FOR USE: .
The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate:
- . Stroke rehabilitation by muscle re-education
- 트 Maintaining or increasing range of motion
TECHNICAL CHARACTERISTICS:
The Able-X is a stroke rehabilitation system that uses a virtual reality based training system to promote therapeutic bilateral movement exercises. The Able-X is comprised of a lightweight polymer handlebar with a wireless game controller mounted at one end and a fixed hand vertical hand grip at the other end of the bar. The wireless controller communicates via a USB receiver dongle to a computer installed with therapeutic exercise games. Game play of the therapeutic exercises is controlled through the game controller and displayed in real-time on the computer screen. The Able-X is incorporated as part of a patient's overall physical therapy program by their healthcare provider.
PERFORMANCE DATA:
Testing confirms that the Able-X can be used according to its intended use and in an equivalent manner to the predicate devices.
BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE:
The Able-X is substantially equivalent to the listed predicate devices with respect to their indications for use (intended use) and technical characteristics. The information and data provided in this 510(k) submission identifies no new safety or effectiveness issues.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with stylized lines representing its wings and body.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
JUN 200 2012
Im-Able Ltd c/o Medtech Consultants, Inc Sigi Caron 2400 Via Carillo Palos Verdes Estates, California 90274
Re: K120783 Trade/Device Name: Able-X Regulation Number: 21 CFR 890.5370 Regulation Name: Nonmeasuring exercise equipment Regulatory Class: Class I Product Code: ION Dated: March 9, 2012 Received: May 10, 2012
Dear Sigi Caron:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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Page 2 - Sigi Caron
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHQffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark V. Melling
Mark N. Mel Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 1.
1. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K120783
Device Name: Able-X
Indications for Use:
The Able-X is indicated for use by stroke patients undergoing upper limb rehabilitation to facilitate: :
- Stroke rehabilitation by muscle re-education
- Maintaining or increasing range of motion
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use ਮ (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K120783
Page of
I'm Able, Ltd. Able X: Stroke Rehabilitation Aid Traditional 510(k) Page 17 of 236
§ 890.5370 Nonmeasuring exercise equipment.
Link to an amendment published at 90 FR 55995, Dec. 4, 2025. (a)
Identification. Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, regarding general requirements concerning records and § 820.198, regarding complaint files.