ULE-2, MULE-2, HAND ACCESSORY KIT

K962855 · Penny and Giles Biometrics , Ltd. · ISD · Dec 11, 1996 · Physical Medicine

Device Facts

• Record ID: K962855
• Device Name: ULE-2, MULE-2, HAND ACCESSORY KIT
• Applicant: Penny and Giles Biometrics , Ltd.
• Product Code: ISD · Physical Medicine
• Decision Date: Dec 11, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 890.5360
• Device Class: Class 2
• Attributes: Therapeutic

Device Story

Rehabilitation/training exercise device; patient-operated via grip; no energy exchange between device and patient; therapist-determined activity duration/extent; non-invasive; no patient attachment. Electrical safety features include 4Kv opto-isolation of data outputs and low voltage DC power supply, plus primary insulation.

Clinical Evidence

No clinical data provided; manufacturer directs attention to Verification and Validation section for effectiveness evidence.

Technological Characteristics

Passive exercise equipment; electrical components include 4Kv opto-isolation for data outputs and low voltage DC power supply; primary insulation; non-invasive grip-based interface.

Regulatory Classification

Identification

Measuring exercise equipment consist of manual devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. These devices also include instrumentation, such as the pulse rate monitor, that provide information used for physical evaluation and physical planning purposes., Examples include a therapeutic exercise bicycle with measuring instrumentation, a manually propelled treadmill with measuring instrumentation, and a rowing machine with measuring instrumentation.

Special Controls

*Classification.* Class II (special controls). The device, when it is a measuring exerciser or an interactive rehabilitation exercise device for prescription use only, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 890.9.

Predicate Devices

• Passive Safety (K962855)

Submission Summary (Full Text)

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# SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION CONTAINED IN THIS SUBMISSION

1. Passive Safety - K 962855 DEC 11 1996

a. At all times the extent and duration of activity is determined by the therapist. (Appendix 1)
b. The equipment provides an aid to the rehabilitation or training of the patient, but does not force the patient to undertake any activity. (Appendix 1)
c. There is no energy exchange between exercise device and patient; (Appendix 1)
d. The patient is not attached to the equipment in any way other than by the patients’ grip. (Appendix 1)

2. Electrical Safety -

a) Opto isolation of data outputs to 4Kv (Appendix 6)
b) Isolation of low voltage DC power supply to 4Kv (Appendix 6)
c) Primary insulation in addition to A and B (Appendix 5)

3. Effectiveness -

Penny and Giles Biometrics makes no claims for the effectiveness of this equipment, but wishes to direct the attention of the examiners to the reports included as the Verification and Validation section of this document.