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510(k) K250309

BTL-199 by BTL Industries, Inc. — Product Code QPL

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: August 7, 2025
Date Received: February 3, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Electromagnetic Stimulator, Pain Relief
Device Class: Class II
Regulation Number: 882.5890
Review Panel: PM
Submission Type

Intended to apply a magnetic-field induced electrical current to treat pain.

Other clearances by BTL Industries, Inc.

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K242532 — BTL-785BNF-E (December 13, 2024)
K240234 — BTL-899MS (August 17, 2024)
K233849 — BTL-499 (April 23, 2024)
K233604 — BTL-785S (March 28, 2024)
K230657 — BTL-99-OC (February 1, 2024)
K232937 — BTL-899M (December 26, 2023)