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PainCare S21

by Micro Current Technology, Inc.

PainCare S21 (MF-105) is a medical device (FDA Class II; FDA product code GZJ, Stimulator, Nerve, Transcutaneous, For Pain Relief) made by Micro Current Technology, Inc., cleared under FDA 510(k) K033253 on 21 Oct 2003 and listed in FDA GUDID since 15 Mar 2018 (UDI-DI 00817076010860), active as of 22 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

510(k) K033253

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00817076010860 UDI-DI Date15 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK033253 Date21 Oct 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K033253 decided 21 Oct 2003 Active
  • FDA GUDID UDI-DI 00817076010860 listed 15 Mar 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K033253
  2. Listed FDA GUDID 00817076010860

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PainCare
Generic name
Analgesic transcutaneous electrical nerve stimulation system
Model / Ref / Catalog
S21, MF-105
Primary DI / UDI-DI
00817076010860
510(k) Number
FDA product code
GZJ
GMDN term
Analgesic transcutaneous electrical nerve stimulation system
Device class
Class II
Regulation number
882.5890
GUDID distribution status
In Commercial Distribution

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Other devices filed under Analgesic transcutaneous electrical nerve stimulation system.

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)