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Bio Protech MaxEMS 2k

by Bio Protech USA, Inc.

Bio Protech MaxEMS 2k is a medical device (FDA Class II; FDA product code IPF, Stimulator, Muscle, Powered) made by Bio Protech USA, Inc., cleared under FDA 510(k) K091248 on 30 Nov 2009 and listed in FDA GUDID since 17 Jun 2016 (UDI-DI 00817120020081), 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) K091248

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 Number00817120020081 UDI-DI Date17 Jun 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK091248 Date30 Nov 2009DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K091248 decided 30 Nov 2009 Active
  • FDA GUDID UDI-DI 00817120020081 listed 17 Jun 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K091248
  2. Listed FDA GUDID 00817120020081

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Bio Protech
Generic name
Physical therapy transcutaneous neuromuscular electrical stimulation system
Model / reference
MaxEMS 2k
Primary DI / UDI-DI
00817120020081
510(k) Number
FDA product code
IPF
GMDN term
Physical therapy transcutaneous neuromuscular electrical stimulation system
Device class
Class II
Regulation number
890.5850
GUDID distribution status
In Commercial Distribution

Related devices

Category: Physical therapy transcutaneous neuromuscular electrical stimulation system

Cleared under the same submission (K091248)

and 1 more cleared under K091248

Similar devices

Other devices filed under FDA product code IPF (Stimulator, Muscle, Powered).

Other devices from Bio Protech USA, Inc.

See all devices from Bio Protech USA, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (8, all answered No)