9019.10.20/TENS EMS Combination Therapy Unit/Japan

TENS EMS Combination Therapy Unit from Japan

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.

Duty Rate — Japan → United States

12.5%

Rate breakdown

9903.05.4912.5%Section 301 (forced labor) — Japan (col1 rate < 12.5 percent): MFN < 12.5% → total duty capped at 12.5%

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Import Tips

• 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