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Pain Therapy Device

by Guangzhou Xinbo Electronic Co., Ltd 2 variants

510(k) K202638

Pain Therapy Device is a medical device (FDA Class II; FDA product code NGX, Stimulator, Muscle, Powered, For Muscle Conditioning) made by Guangzhou Xinbo Electronic Co., Ltd, cleared under FDA 510(k) K202638 on 15 Jul 2021, active as of 8 Nov 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 8 Nov 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK202638 Date15 Jul 2021ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
NGX
FDA applicant
Guangzhou Xinbo Electronic Co., Ltd.
Device class
Class II
Regulation
21 CFR Part 890.5850
Advisory committee
Physical Medicine
FDA decision
SESE Substantially Equivalent

Devices cleared under K202638

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K202638
UDI-DISize and differences
DR -HOS P.T.S-III
Guangzhou Xinbo Electronic Co., Ltd.
P.T.S-III06970742221824 —On the market

Similar devices

Other devices filed under FDA product code NGX (Stimulator, Muscle, Powered, For Muscle Conditioning).

Other devices from Guangzhou Xinbo Electronic Co., Ltd

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