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510(k) 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, DH-CP-I) by Guangzhou Xinbo Electronic Co., Ltd. — Product Code NGX

K212948 is an FDA 510(k) premarket notification submitted by Guangzhou Xinbo Electronic Co., Ltd. for the device "Pain Therapy Device(Model: DH-P.T.S-I, DH-P.T.S-II, DH-P.T.S-IIA, DH-P.T.S-IIB, DH-CP-I)". The FDA issued a decision of Substantially Equivalent on November 1, 2021. The device falls under product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning), a Class II device regulated under 21 CFR 890.5850. Guangzhou Xinbo Electronic Co., Ltd. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 1, 2021
Date Received
September 16, 2021
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Stimulator, Muscle, Powered, For Muscle Conditioning
Device Class
Class II
Regulation Number
890.5850
Review Panel
PM
Submission Type

A powered muscle stimulator for muscle conditioning is a device used for other than medical purposes to apply an electrical current to electrodes on a person's skin to temporarily affect the stimulated muscle's contractile properties, force output, and/or fatigue resistance. Unlike the classified Powered Muscle Stimulator devices intended for use in physical medicine and rehabilitation, this device is not intended for use in patients with medical conditions and is intended only for muscle conditioning purposes.

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)
  • K202671 — DR-HO's Back Pain Relief System Pro (Models BPRS-I and BPRS-II) (November 12, 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)

Other clearances for product code NGX

  • K253926 — Diacore (April 10, 2026)
  • K253636 — Zionic Pro Max (EMS) (March 12, 2026)
  • K253408 — CoolTone (January 16, 2026)
  • K252154 — Portable Electro Stimulation Therapy Device (LGT-2320BE, LGT-2320ME, and LGT-232 (December 9, 2025)
  • K253478 — Motive™ Muscle Stimulator for Lower Back (OT01-1003) (November 6, 2025)
  • K251594 — truFlex (August 28, 2025)
  • K251706 — TENS and EMS Unit (July 30, 2025)
  • K251378 — CoolTone (July 14, 2025)
  • K251746 — Pure Impact (July 2, 2025)
  • K250759 — 3 in 1 TENS UNIT (June 13, 2025)

FDA data resources