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Painvision Ps-2100

by Sanyo Seiko Co., Ltd. GUDID

Listed (no authorization) FDA GUDID database listing only

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04573224000317 UDI-DIDate22 May 2026ListedStatusIn distribution

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 23 Oct 2026.

Specification

GUDID

Trade Name
Painvision
Generic Name
Somatosensory electrical stimulation system
Model / Reference
PS-2100
Primary DI / UDI-DI
04573224000317
510(k) Number
FDA Product Code
LLN
GMDN Term
Somatosensory electrical stimulation system
Device Class
Class I
Regulation Number
882.1200
Commercial Distribution
In Commercial Distribution

Properties

  • Serial Number
  • Manufacturing Date

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No