← Product Code [IPF](/productcode/IPF) · K950550 # XH-1 NEUROMUSCULAR STIMULATOR (K950550) _California Medical Research Institute · IPF · Dec 4, 1996 · Physical Medicine · SESE_ **Canonical URL:** https://fda-staging.innolitics.com/device/K950550 ## Device Facts - **Applicant:** California Medical Research Institute - **Product Code:** [IPF](/productcode/IPF.md) - **Decision Date:** Dec 4, 1996 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 890.5850 - **Device Class:** Class 2 - **Review Panel:** Physical Medicine - **Attributes:** Therapeutic ## Device Story XH-1 Neuromuscular Stimulator is a powered muscle stimulator used to relax muscle spasms. Device operates at a fixed frequency of 0.9 Hz, delivering a biphasic waveform without direct current. Input power is provided by two AA batteries (3 volts). Output is delivered via electrodes coupled to the skin using a water-moistened paper towel. Device maintains a fixed pulse-width under constant resistant load and provides continuous output with an interpulse rest period of approximately 1.1 seconds. Peak output is +110V/-110V and +11mA/-11mA into a 10,000-ohm load. Device is intended for clinical use, building upon a history of similar neuromuscular stimulation technology. ## Clinical Evidence No clinical data provided. Substantial equivalence is based on technical feature comparison and historical clinical usage of similar neuromuscular stimulators since 1987. ## Technological Characteristics Powered muscle stimulator; biphasic waveform; fixed frequency 0.9 Hz; fixed pulse-width; 3V power source (2 AA batteries); electrode coupling via water-moistened paper towel; output peak +110V/-110V, +11mA/-11mA (10k ohm load). ## Regulatory Identification A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area. ## Predicate Devices - Myopulse Neuromuscular Stimulator ## Reference Devices - [K840346](/device/K840346.md) - [K926510](/device/K926510.md) - [K850013](/device/K850013.md) - [K893878](/device/K893878.md) - [K893879](/device/K893879.md) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} K95055U "This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA and 21 CFR §807.92." SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION OF SUBSTANTIAL EQUIVALENCE ON THE MAIN TECHNICAL FEATURES BETWEEN THE XH-1 NEUROMUSCULAR STIMULATOR AND THE MYOPULSE NEUROMUSCULAR STIMULATOR | No. | Item | XH-1, a powered muscle stimulator | Myopulse, a powered muscle stimulator | Level of Safety and Effectiveness | | --- | --- | --- | --- | --- | | 1 | Frequency 0.9 Hz | Equivalent | Equivalent | Equivalent | | 2 | Biphasic wave without direct current | Equivalent | Equivalent | Equivalent | | 3 | Wave Form | Similar | Similar | Equivalent | | 4 | Pulse peak output voltage and current, 10,000 ohms load. | +110volts, -110volts. +11mAmp, -11mAmp. | +90volts -115volts. +9mAmp, -11.5mAmp. | Equivalent | | 5 | Output frequency fixed. | Equivalent | Equivalent | Equivalent | | 6 | Output pulse-width fixed under a constant resistant load. | Equivalent | Equivalent | Equivalent | | 7 | Interpulse rest of approximately 1.1 second. | Equivalent | Equivalent | Equivalent | | 8 | @ 0.9 Hz frequency, continuous output | Equivalent | Equivalent | Equivalent | | 9 | Average output current, 10,000 ohms load. | 0.18mAmp | 0.013 mAmp | Equivalent* | | 10 | Frugal on electrical consumption | Two AA batteries, 3volts, can operate for 700 hours. | One 9volt batter. can operate for 350 hours. | Equivalent | | 11 | Electrode Coupling Medium | Paper towel moistened with water. | Sponge moistened with water. | Equivalent | | 12 | Function: to relax muscle spasm | Equivalent | Equivalent | Equivalent | | 13 | History of clinical usage | Since 1987 to present | Since 1968 to present | Equivalent | | 14 | Adverse effects are not known. | Equivalent | Equivalent | Equivalent | | *Dangerous current levels are those above about 15 milliamps, but below 1 milliamp is considered completely safe to the human body according to the Federal Engineering department associated with the National Electric Code and according to the State of California OSHA Consultation Group. | | | | | The 14 main technical features in the summary prove that the XH-1 Neuromuscular Stimulator is substantially equivalent, in terms of safety and effectiveness, to the Myopulse Neuromuscular Stimulator, which is a preamendment device marketed prior to May 28, 1976. fa Lin Dr. Laiyin Yan alias Fa Lin CALIFORNIA MEDICAL RESEARCH INSTITUTE January 17, 1995 {1} COMPARISON CHART OF THE SIMILARITIES OF MAIN TECHNICAL FEATURES BETWEEN THE XH-1 NEUROMUSCULAR STIMULATOR AND OTHER ELECTRICAL MUSCLE STIMULATORS WITH 510(K) NUMBER | No. | Item | XH-1 | Other Products | | --- | --- | --- | --- | | 1 | Neuromuscular Stimulator as proprietary name | Equivalent | Those with equivalent proprietary names: K840346 K926510 | | 2 | Frequency of 1 Hz | 0.9 Hz | Those that can be adjusted to 1 Hz output: K850013 K893878 K893879 | | 3 | Interpulse resting time of approximately 1 second | 1.1 second | Those that can be adjusted to 1-second off time: K893878 K893879 K926510 | | 4 | Pulses with continuous output | At 0.9 Hz, continuous output | Those that can be adjusted to continuous output: K840346 K926510 | not same at device having only a 1 Hz output. "can" have continuous output fa Lin Dr. Laiyin Yan CALIFORNIA MEDICAL RESEARCH INSTITUTE U.S.A. January, 1995 --- **Source:** [https://fda-staging.innolitics.com/device/K950550](https://fda-staging.innolitics.com/device/K950550) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com