Counter PTS-IV

by Counter Scientific Development (Gz), Ltd.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

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

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number06970368250017 UDI-DI	Date8 Mar 2021Listed	StatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name: Counter
Generic Name: Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / Reference: PTS-IV

Primary DI / UDI-DI: 06970368250017
510(k) Number: K161537
FDA Product Code: NUH
GMDN Term: Physical therapy transcutaneous neuromuscular electrical stimulation system

Device Class: Class II
Regulation Number: 882.5890
GUDID distribution status: In Commercial Distribution

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Properties

Over-the-Counter
Lot / Batch Number
Manufacturing Date

Other properties (11)

Sterile: No
Single Use: No
Implantable: No
Contains Latex: No
Prescription Use: No
Convenience Kit: No
Combination Product: No
HCT/P: No
Premarket Exempt: No
Serial Number: No
Expiration Date: No