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510(k) K202671

DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) by Guangzhou Xinbo Electronic Co., Ltd. — Product Code NUH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 2021
Date Received
September 14, 2020
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Nerve, Transcutaneous, Over-The-Counter
Device Class
Class II
Regulation Number
882.5890
Review Panel
NE
Submission Type

TEMPORARY RELIEF OF PAIN DUE TO SORE/ACHING MUSCLES

Other clearances by Guangzhou Xinbo Electronic Co., Ltd.

  • K230711 — Pain Therapy Device(Model: P.T.S-X) (May 16, 2024)
  • K231789 — Pain Therapy Device (Model: P.T.S-VI, P.T.S-VII) (March 11, 2024)
  • K231167 — Conductive Silicone Rubber Electrode (August 9, 2023)
  • K231164 — Conductive carbon film electrode (August 9, 2023)
  • K212948 — Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, (November 1, 2021)
  • K202636 — Metallic Fabric Electrodes (August 16, 2021)
  • K202638 — Pain Therapy Device (July 15, 2021)
  • K200402 — DR-HO'S Electro Therapy Conductive Gel (November 25, 2020)
  • K190118 — Dr-Ho's Foot Pad Electrode (Models: DHFRE-I, CP-I, CP-II, CP-III) (May 13, 2020)
  • K172887 — XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therap (April 19, 2018)

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