TENS EMS Combination Therapy Unit
Portable TENS/EMS device delivering electrical muscle stimulation and pain-blocking transcutaneous nerve impulses for physical therapy. While primarily electrical, mechanical muscle activation qualifies under HTS 9019.10.20 mechano-therapy classification.
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More Specific Codes
This product may fall under a more specific subheading:
Alternative Classifications
This product could be classified differently depending on its characteristics or intended use.
If classified as electro-diagnostic nerve/muscle stimulator
Diagnostic electro-medical apparatus excludes therapeutic mechano-therapy
If for non-medical electrical stimulators
Other electrical machines principally for non-therapeutic stimulation
If for electrode pads/accessories sold separately
Accessories suitable for general use with Chapter 90 apparatus
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Import Tips & Compliance
• Secure FDA Class II 510(k) clearance; maintain Device Master Record for customs audit
• Include clinical protocols demonstrating TENS vs EMS therapeutic distinctions
• Declare maximum output parameters (mA, Hz, pulse width) per FDA labeling requirements
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