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5000Z System (Otc)

by Prizm Medical, Inc.

510(k) K033122

5000Z System (Otc) is a medical device (FDA Class II; FDA product code NUH, Stimulator, Nerve, Transcutaneous, Over-The-Counter) made by Prizm Medical, Inc., cleared under FDA 510(k) K033122 on 25 Aug 2004, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK033122 Date25 Aug 2004ClearedStatusActive

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  • Withdrawn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
NUH
Device class
Class II
Regulation
21 CFR Part 882.5890
Advisory committee
Neurology
FDA decision
SESU

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K033122

2 devices · 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 K033122
UDI-DISize and differences
ReviStim REVSTM2
Prizm Medical, Inc.
REVSTM2B872REVSTM20 —On the market
Sport-Z SPZ200
Prizm Medical, Inc.
SPZ200B872SPZ2000 —On the market

Similar devices

Other devices filed under FDA product code NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter).

Other devices from Prizm Medical, Inc.

See all devices from Prizm Medical, Inc. →