ION · Exerciser, Non-Measuring
Physical Medicine · 21 CFR 890.5370 · Class 1
Overview
| Product Code | ION |
|---|---|
| Device Name | Exerciser, Non-Measuring |
| Regulation | 21 CFR 890.5370 |
| Device Class | Class 1 |
| Review Panel | Physical Medicine |
| GMP Exempt | Yes |
Identification
Nonmeasuring exercise equipment consist of devices intended for medical purposes, such as to redevelop muscles or restore motion to joints or for use as an adjunct treatment for obesity. Examples include a prone scooter board, parallel bars, a mechanical treadmill, an exercise table, and a manually propelled exercise bicycle.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 890.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (20 of 43)
Showing 20 most recent of 43 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120783 | ABLE-X | Im-Able, Ltd. | Jun 20, 2012 | SESE |
| K885343 | STANDEX | Alt, Inc. | May 1, 1989 | SESE |
| K851065 | GRAVITY KING (DEEMED SE 87/09/18) | Unique Functional Products | Jun 13, 1985 | SESE |
| K840551 | MOBILIZER | Lossing Orthopedic, Inc. | Mar 23, 1984 | SESE |
| K833870 | KNEE WALKER | Maddak, Inc. | Nov 29, 1983 | SESE |
| K833249 | FITNESS | Fitness Equipment Co., Inc. | Nov 7, 1983 | SESE |
| K832968 | PEDAL EXERCISER | Maddak, Inc. | Sep 29, 1983 | SESE |
| K831543 | ADJUST. WEIGHTS-BK5171-05,10,20 BEOK | Fred Sammons, Inc. | Jun 24, 1983 | SESE |
| K831538 | DELUXE ADJUST-ANGLE BOARD-BK4066 | Fred Sammons, Inc. | Jun 8, 1983 | SESE |
| K831033 | GIREX | Lancer Assoc. | Apr 27, 1983 | SESE |
| K830560 | EXERCISER, PASSIVE, NON MEASURING | Kaye Products, Inc. | Mar 9, 1983 | SESE |
| K830400 | MADDATRAINER HAND EXERCISER | Maddak, Inc. | Mar 9, 1983 | SESE |
| K823236 | BACK ON TRACK INVERSION THERAPY & EXER | Lossing Orthopedic, Inc. | Jan 21, 1983 | SESE |
| K823623 | INFLATABLE HEAVY PLASTIC EXERCISER | Fred Sammons, Inc. | Dec 28, 1982 | SESE |
| K823620 | PLASTIC ELASTOMER IN CUBE FORM EXERCISE | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823619 | PLASTIC ELASTOMER ENCASED IN TERRY CLOTH | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K823618 | PROGRESSIVE RESISTANCE EXERCISE CUFF | Fred Sammons, Inc. | Dec 22, 1982 | SESE |
| K822906 | PHYSICAL MEDICINE & REHABILITATION EQUIP | I-Rep, Inc. | Oct 15, 1982 | SESE |
| K821857 | BK-5305 MULTIPLE HAND GRID | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
| K821855 | VISCO HANDEX-VARIOUS MODELS | Fred Sammons, Inc. | Jul 2, 1982 | SESE |
Top Applicants
- Fred Sammons, Inc. — 18 clearances
- Maddak, Inc. — 7 clearances
- Hosmer Dorrance Corp. — 2 clearances
- Lossing Orthopedic, Inc. — 2 clearances
- Alt, Inc. — 1 clearance
