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ReCure Patient Electrode Kit - Patient US

by Niche Biomedical, Inc.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850053287428 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
ReCure
Generic Name
Spinal cord rehabilitation transcutaneous electrical stimulation system
Model / Ref / Catalog
Patient Electrode Kit - Patient US, PEK91001
Primary DI / UDI-DI
00850053287428
510(k) Number
FDA Product Code
SDO, GXY
GMDN Term
Spinal cord rehabilitation transcutaneous electrical stimulation system
Device Class
Class II
Regulation Number
890.5851, 882.1320
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Related devices

Cleared under the same submission (K252893)

Show all (12)

Other devices from Niche Biomedical, Inc.

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Properties

  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date

Other properties (10)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No